358 Daridorexant Improves Sleep in Patients with Mild/Moderate Obstructive Sleep Apnea

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A143-A143
Author(s):  
Marie-Laure Boof ◽  
Ingo Fietze ◽  
Katharina Lederer ◽  
Anne-Sophie Guern ◽  
Vincent Lemoine ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Sleep Duration ◽  
Sleep Onset ◽  
Sleep Architecture ◽  
Sleep Stages ◽  
Apnea Hypopnea Index ◽  
Treatment Difference ◽  
Obstructive Sleep ◽  
Sleep Parameters

Abstract Introduction Daridorexant is a dual orexin receptor antagonist developed for the treatment of insomnia. The effect of the highest phase-3 dose of 50 mg daridorexant on nighttime respiratory function was evaluated in patients with mild/moderate obstructive sleep apnea (OSA). This study showed that repeated doses of daridorexant had no clinically meaningful effect on the apnea-hypopnea index (AHI) or on peripheral oxygen saturation. In the same study, the effect on objective sleep parameters was also explored by polysomnography (PSG). Methods In this randomized, double-blind, placebo-controlled, two-period, crossover study, daridorexant or placebo was administered in each period once daily for 5 consecutive nights to 28 patients. Treatment difference (daridorexant – placebo) for total sleep time (TST), latency to persistent sleep (LPS), and wake after sleep onset (WASO) was analyzed for Night 5 using linear mixed-effects modeling. In addition, sleep was further explored based on sleep duration during each hour of PSG recording, duration of the different sleep phases (rapid eye movement [REM], non-REM [including N1 to N3 sleep stages]), as well as number and mean/longest duration of awakenings. Results Of 28 patients enrolled, 25 completed the study and were included in the analysis (n=15/10 with mild/moderate OSA; mean [standard deviation] AHI: 16.3 [8.2] events/h). One patient had mild insomnia symptoms at baseline. Compared to placebo, daridorexant prolonged mean TST by 38.8 min (90% confidence interval: 19.7–57.9), shortened mean LPS by 17.2 min (-35.5–1.02), and reduced mean WASO by 31.0 min (-47.3 to 14.7). Sleep architecture was maintained as no treatment differences in the duration of the evaluated sleep stages were observed when normalized to TST. Sleep duration was prolonged in the second part of the night. mean and longest duration of awakenings were decreased by a mean (90% CI) of 2.0 min (-3.1 to 0.9) and 16.3 min (-24.1 to -8.6), respectively, without treatment difference for the total number of awakenings. Conclusion Daridorexant improved objective sleep parameters in patients with mild to moderate OSA without modifying sleep architecture. Support (if any) Funded by Idorsia Pharmaceuticals Ltd.

Effect of the new dual orexin receptor antagonist daridorexant on nighttime respiratory function and sleep in patients with mild and moderate obstructive sleep apnea

SLEEP ◽  
2020 ◽  
Author(s):  
Marie-Laure Boof ◽  
Jasper Dingemanse ◽  
Katharina Lederer ◽  
Ingo Fietze ◽  
Mike Ufer
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Receptor Antagonist ◽  
Respiratory Function ◽  
Plasma Concentrations ◽  
Sleep Onset ◽  
Apnea Hypopnea Index ◽  
Treatment Difference ◽  
Obstructive Sleep ◽  
Repeated Dosing

Abstract In this randomized, double-blind, placebo-controlled, two-period crossover study, the effect of the dual orexin receptor antagonist daridorexant was evaluated on nighttime respiratory function and sleep in 28 patients with mild and moderate obstructive sleep apnea (OSA). In each period, 50 mg daridorexant or placebo was administered every evening for 5 days. The primary endpoint was apnea/hypopnea index (AHI) during total sleep time (TST) after the last dosing. Other endpoints included peripheral oxygen saturation (SpO2), sleep duration, latency to persistent sleep (LPS), wake after sleep onset (WASO), and sleep efficiency index (SEI). Pharmacokinetics, safety, and tolerability were also assessed. The mean treatment difference for AHI during TST (i.e. daridorexant − placebo) after the last dosing was 0.74 events/hour (90% confidence interval [CI]: –1.43, 2.92). The corresponding treatment difference for SpO2 during TST was 0.16% [90% CI: –0.21, 0.53]. Overall, there was no clinically relevant effect of daridorexant on AHI or SpO2-related data after single and repeated dosing irrespective of sleep phase (i.e. rapid eye movement [REM] vs non-REM). Moreover, after single and repeated dosing, daridorexant prolonged TST by 39.6 minutes (90% CI: 16.9, 62.3) and 38.8 minutes (19.7, 57.9), respectively, compared with placebo and favorably modulated other sleep-related endpoints (i.e. increased SEI, decreased WASO, and shortened LPS). It attained expected plasma concentrations and was well tolerated in patients with mild and moderate OSA. These results indicate that single and repeated doses of 50 mg daridorexant do not impair nighttime respiratory function and improve sleep in patients with mild and moderate OSA. Clinical Trial Registration ClinicalTrials.gov NCT03765294. A study to investigate the effects of ACT-541468 on nighttime respiratory function in patients with mild to moderate obstructive sleep apnea. https://clinicaltrials.gov/ct2/show/ NCT03765294.

scholarly journals Randomized controlled trial of an integrated approach to treating insomnia and improving the use of positive airway pressure therapy in veterans with comorbid insomnia disorder and obstructive sleep apnea

SLEEP ◽  
2020 ◽  
Author(s):  
Cathy A Alessi ◽  
Constance H Fung ◽  
Joseph M Dzierzewski ◽  
Lavinia Fiorentino ◽  
Carl Stepnowsky ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Airway Pressure ◽  
Positive Airway Pressure ◽  
Sleep Onset ◽  
Apnea Hypopnea Index ◽  
Sleep Onset Latency ◽  
Pressure Therapy ◽  
Comorbid Insomnia ◽  
Obstructive Sleep

Abstract Study Objectives Cognitive behavioral therapy for insomnia (CBTI) for comorbid insomnia and obstructive sleep apnea (OSA) has had mixed results. We integrated CBTI with a positive airway pressure (PAP) adherence program and tested effects on sleep and PAP use. Methods 125 veterans (mean age 63.2, 96% men, 39% non-Hispanic white, 26% black/African American, 18% Hispanic/Latino) with comorbid insomnia and newly-diagnosed OSA (apnea-hypopnea index ≥ 15) were randomized to 5-weekly sessions integrating CBTI with a PAP adherence program provided by a “sleep coach” (with behavioral sleep medicine supervision), or 5-weekly sleep education control sessions. Participants and assessment staff were blinded to group assignment. Outcomes (baseline, 3 and 6 months) included Pittsburgh Sleep Quality Index (PSQI), 7-day sleep diary (sleep onset latency [SOL-D], wake after sleep onset [WASO-D], sleep efficiency [SE-D]), 7-day actigraphy (SE-A), and objective PAP use (hours/night and nights ≥ 4 h). Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) were also collected. Results Compared to controls, intervention participants showed greater improvement (baseline to 3 and 6 months, respectively) in PSQI (−3.2 and −1.7), SOL-D (−16.2 and −15.5 minutes), SE-D (10.5% and 8.5%), SE-A (4.4% and 2.6%) and more 90-day PAP use (1.3 and 0.9 more hours/night, 17.4 and 11.3 more nights PAP ≥ 4 h). 90-day PAP use at 3 months was 3.2 and 1.9 h/night in intervention versus controls. Intervention participants also had greater improvements in ISI, ESS, and FOSQ-10 (all p < 0.05). Conclusions An intervention integrating CBTI with a PAP adherence program delivered by a supervised sleep coach improved sleep and PAP use in adults with comorbid insomnia and OSA. Trial Registration ClinicalTrials.gov Study name: Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans URL: https://clinicaltrials.gov/ct2/results?cond=&term=NCT02027558&cntry=&state=&city=&dist= Registration: NCT02027558

Postoperative Changes in Sleep-disordered Breathing and Sleep Architecture in Patients with Obstructive Sleep Apnea

2014 ◽  
Vol 120 (2) ◽  
pp. 287-298 ◽  
Author(s):  
Frances Chung ◽  
Pu Liao ◽  
Balaji Yegneswaran ◽  
Colin M. Shapiro ◽  
Weimin Kang
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Sleep Disordered Breathing ◽  
Slow Wave Sleep ◽  
Sleep Architecture ◽  
Secondary Outcome ◽  
Apnea Hypopnea Index ◽  
Postoperative Changes ◽  
Obstructive Sleep ◽  
Disordered Breathing

Abstract Background: Anesthetics, analgesics, and surgery may profoundly affect sleep architecture and aggravate sleep-related breathing disturbances. The authors hypothesized that patients with preoperative polysomnographic evidence of obstructive sleep apnea (OSA) would experience greater changes in these parameters than patients without OSA. Methods: After obtaining approvals from the Institutional Review Boards, consented patients underwent portable polysomnography preoperatively and on postoperative nights (N) 1, 3, 5, and 7 at home or in hospital. The primary and secondary outcome measurements were polysomnographic parameters of sleep-disordered breathing and sleep architecture. Results: Of the 58 patients completed the study, 38 patients had OSA (apnea hypopnea index [AHI] >5) with median preoperative AHI of 18 events per hour and 20 non-OSA patients had median preoperative AHI of 2. AHI was increased after surgery in both OSA and non-OSA patients (P < 0.05), with peak increase on postoperative N3 (OSA vs. non-OSA, 29 [14, 57] vs. 8 [2, 18], median [25th, 75th percentile], P < 0.05). Hypopnea index accounted for 72% of the postoperative increase in AHI. The central apnea index was low (median = 0) but was significantly increased on postoperative N1 in only non-OSA patients. Sleep efficiency, rapid eye movement sleep, and slow-wave sleep were decreased on N1 in both groups, with gradual recovery. Conclusions: Postoperatively, sleep architecture was disturbed and AHI was increased in both OSA and non-OSA patients. Although the disturbances in sleep architecture were greatest on postoperative N1, breathing disturbances during sleep were greatest on postoperative N3.

scholarly journals 0879 Outcomes of Adenotonsillectomy in Children with Down Syndrome and Obstructive Sleep Apnea

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A335-A335
Author(s):  
A Morello Gearhart ◽  
B Gunaratnam ◽  
E Senthilvel
Keyword(s):  
Obstructive Sleep Apnea ◽  
Down Syndrome ◽  
Sleep Apnea ◽  
Sleep Onset ◽  
Sleep Efficiency ◽  
Apnea Hypopnea Index ◽  
P Value ◽  
Children With Down Syndrome ◽  
Arousal Index ◽  
Obstructive Sleep

Abstract Introduction Obstructive sleep apnea (OSA) is highly prevalent in children with Down Syndrome (DS). The aim of this study was to assess the effectiveness of adenotonsillectomy (T&A) on polysomnographic parameters of children with DS. Methods Retrospective chart review of children with DS who underwent T&A between 2012-2019 was performed. Preoperative OSA severity was categorized by obstructive apnea-hypopnea index (OAHI): mild = 1-4.9 events/h; moderate = 5-9.9 events/h; severe ≥ 10 events/h. Results We identified 43 DS children with pre and post T&A polysomnographic data in a population of 162 DS patients. A total of 25 were male, mean age 5.1 years (± 3.8 years) and 56% Caucasians. Preoperative data showed 19% mild OSA, 30% moderate and 51% severe. Postoperatively, apnea-hypopnea index (AHI) normalized in 9.3%, 37.2% had mild OSA, 18.6% moderate and 34.9% severe. Overall, T&A resulted in significant improvement (p-value <0.05) in mean AHI, (18.51 ± 28.05 vs 11.72 ± 16.43), SaO2 nadir (80.00 ± 14.82 vs 85.51 ± 5.94), sleep efficiency (81.97 ± 11.15 vs 85.9 ± 8.28), arousal index (16.14 ± 10.23 vs 14.45 ± 12.34), and wake after sleep onset (67.19 ± 46.89 vs 50.55 ± 40.83) and no statistical difference (p-value >0.05) in end-tidal carbon dioxide (43.86 ± 9.56 vs 44.17 ± 3.78), Rapid Eye Movement (REM)% (15.86 ± 7.75 vs 15.92 ± 7.41), sleep latency (24.03 ± 34.39 vs 22.55 ± 21.11), and central apnea index (0.86 ± 1.38 vs 0.66 ± 0.82) in pre and post T&A data. There was no statistically significant difference in pre and post T&A polysomnographic parameters between 17 DS and 17 age and gender-matched non-DS control subjects. Conclusion Adenotonsillectomy resulted in improvement in AHI, oxygen desaturation nadir, sleep efficiency, arousal index and wake after sleep onset. However, a significant portion of children with DS continued to have moderate to severe OSA after T&A. Support None.

scholarly journals Obstructive Sleep Apnea, Sleep Duration, and Associated Mediators With Carotid Intima-Media Thickness

2021 ◽  
Author(s):  
Silvana P. Souza ◽  
Ronaldo B. Santos ◽  
Itamar S. Santos ◽  
Barbara K. Parise ◽  
Soraya Giatti ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Sleep Duration ◽  
Intima Media Thickness ◽  
Carotid Intima Media Thickness ◽  
R Package ◽  
Apnea Hypopnea Index ◽  
Sleep Study ◽  
Media Thickness ◽  
Obstructive Sleep

Objective: To elucidate the independent associations of obstructive sleep apnea (OSA) and sleep duration (SD) as well as the potential inflammatory and metabolic mediators on carotid intima-media thickness (CIMT) in a large cohort of adults. Approach and Results: Consecutive participants from the ELSA-Brasil performed a clinical evaluation, sleep study, 1-week actigraphy for defining SD and CIMT using standard techniques. Gamma regression models were used to explore the association between OSA and SD with CIMT. Mediation analysis was performed using the mediation R package. A total of 2009 participants were included in the main analysis. As compared with no OSA (apnea-hypopnea index [AHI] <5 events/hour; n=613), patients with mild (AHI, 5–14.9; n=741), moderate (AHI, 15–29.9; n=389), and severe OSA (AHI ≥30 events/hour; n=266) presented a progressive CIMT increase (0.690 [0.610–0.790], 0.760 [0.650–0.890], 0.810 [0.700–0.940], and 0.820 [0.720–0.958] mm; P <0.001). In contrast, CIMTs were similar for those with SD <6 hours (0.760 [0.650–0.888]), 6 to 8 hours (0.750 [0.640–0.880]) and >8 hours (0.740 [0.670–0.900]). All forms of OSA were independently associated with CIMT (mild: β: 0.019, SE 0.008; P =0.022; moderate: β: 0.025, SE 0.011; P =0.022; severe OSA: β: 0.040, SE 0.013; P =0.002). Moreover, the association of AHI with CIMT was mediated by increased C-reactive protein and triglycerides ( P <0.01). SD did not interact with OSA in the association with CIMT. Conclusions: OSA is independently associated with increased CIMT in a dose-response relationship. This association is partially mediated by inflammation and dyslipidemia. In contrast, SD is not associated nor interacted with OSA to increase CIMT.

scholarly journals Obstructive sleep apnea, nighttime arousals, and leukocyte telomere length: the Multi-Ethnic Study of Atherosclerosis

SLEEP ◽  
2019 ◽  
Vol 42 (7) ◽  
Author(s):  
Judith E Carroll ◽  
Michael R Irwin ◽  
Teresa E Seeman ◽  
Ana V Diez-Roux ◽  
Aric A Prather ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Telomere Length ◽  
Sleep Onset ◽  
Biological Aging ◽  
Apnea Hypopnea Index ◽  
Leukocyte Telomere Length ◽  
Ethnic Study ◽  
Age Related ◽  
Obstructive Sleep

AbstractStudy ObjectivesSleep disturbances and sleep apnea are associated with increased vulnerability to age-related disease, altering molecular pathways affecting biological aging. Telomere length captures one component of biological aging. We evaluated whether objectively assessed sleep and sleep apnea relate to leukocyte telomere length (LTL) in the Multi-Ethnic Study of Atherosclerosis (MESA).MethodsMen and women aged 44–84 years (n = 672) from the MESA Stress and MESA Sleep studies underwent polysomnography and 7 day actigraphy (at Exam 5) and assessment of LTL (at baseline [Exam 1] and about 10 years later [Exam 5]).ResultsGeneral linear models adjusting for age, sex, race/ethnicity, BMI, physical activity, and smoking found that severe obstructive sleep apnea (OSA; apnea–hypopnea index > 30) was cross-sectionally associated with shorter LTL (p = 0.007). Modest associations of shorter LTL with less rapid eye movement sleep, more stage 1 sleep, wake after sleep onset >30 min, and long sleep duration were found, but these effects were diminished after adjusting for lifestyle and OSA. Exploratory analyses found that higher arousal index at Exam 5 was associated with greater LTL decline over the prior 10 years (p = 0.004).ConclusionsOSA was associated with shorter LTL. Individuals with high-arousal frequency had greater leukocyte telomere attrition over the prior decade. These findings suggest that sleep apnea and sleep fragmentation are associated with accelerated biological aging.

scholarly journals Critical closing pressure during midazolam-induced sleep

2011 ◽  
Vol 111 (5) ◽  
pp. 1315-1322 ◽  
Author(s):  
Pedro R. Genta ◽  
Danny J. Eckert ◽  
Marcelo G. Gregorio ◽  
Naury J. Danzi ◽  
Henrique T. Moriya ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Intraclass Correlation ◽  
Sleep Architecture ◽  
Apnea Hypopnea Index ◽  
Low Doses ◽  
Natural Sleep ◽  
Obstructive Sleep ◽  
Critical Closing Pressure ◽  
Closing Pressure

The critical closing pressure (Pcrit) is the airway pressure at which the airway collapses and reflects the anatomical contribution to the genesis of obstructive sleep apnea. Pcrit is usually determined during non-rapid eye movement sleep at night, but has been determined under midazolam sedation during the day in the absence of sleep stage monitoring. Indeed, little is known about the effects of midazolam on sleep architecture. Moreover, deeper sedation with midazolam can decrease upper airway muscle activity and increase collapsibility compared with natural sleep. Pcrit under sedation has not been systematically compared with the usual method performed during natural sleep. Therefore, this study aimed to test the hypothesis that Pcrit following low doses of midazolam during the day would be comparable to Pcrit measured during natural sleep in the same patient. Fifteen men (age 54 ± 10 yr, body mass index 30 ± 4 kg/m2) with obstructive sleep apnea underwent a baseline standard overnight polysomnogram (apnea-hypopnea index 38 ± 22 events/h, range: 8–66 events/h), and Pcrit was determined during natural sleep and following midazolam. Sleep induction was obtained with low doses of midazolam (2.4 mg, range 2.0–4.4 mg), and sleep architecture was comparable to natural sleep. Natural sleep and induced sleep Pcrit were similar (−0.82 ± −3.44 and −0.97 ± 3.21 cmH2O, P = 0.663) and closely associated (intraclass correlation coefficient = 0.92; 95% confidence interval, 0.78–0.97, P < 0.001). Natural and midazolam-induced Pcrit correlated with obstructive sleep apnea severity, indicating that both Pcrit measures provided meaningful physiological information. Pcrit determined during the day with sleep induction is similar to natural overnight sleep and is a valid alternative approach in which to determine Pcrit.

scholarly journals 0560 The Effect of Smoking on OSA Endotypes: A Retrospective Cohort Study

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A215-A215
Author(s):  
S Al-Azzawi ◽  
J E Orr ◽  
P DeYoung ◽  
R L Owens ◽  
A Malhotra ◽  
...  
Keyword(s):  
Sleep Apnea ◽  
Retrospective Cohort ◽  
Sleep Stages ◽  
Apnea Hypopnea Index ◽  
Arousal Threshold ◽  
Obstructive Sleep ◽  
Significant Difference ◽  
Sleep Parameters ◽  
Former Smokers ◽  
Never Smokers

Abstract Introduction Smoking is a purported risk factor for obstructive sleep apnea (OSA), but the mechanisms through which smoking may cause OSA are largely unclear. Our goal is to assess the effect of smoking on the pathophysiological traits (“endotypes”) underlying OSA. Methods Based on a chart review we are creating a retrospective cohort of consecutive patients who were newly diagnosed with OSA based on an inlab polysomnogram between 1/2016 and 6/2018 and who have a documented smoking status. For each subject we are quantifying the endotypes (e.g. arousal threshold, loop gain, upper airway muscle recruitment) via a validated polysomnography-based algorithm. Additionally, we are estimating the arousal threshold based on a clinical prediction score. We are comparing OSA endotypes (primary outcomes), sleep apnea severity (apnea-hypopnea index, SpO2 nadir) and sleep parameters (e.g. total sleep time, sleep efficiency, sleep stages) in current vs former vs never smokers using Kruskal-Wallis tests (+Dunn’s test for post hoc comparisons). Results To date we have screened 334 of 2,138 subjects and identified 99 eligible subjects (5 current smokers at the time of polysomnography, 37 former smokers, and 57 never smokers). The clinical arousal threshold was similar across groups (P=.69); polysomnography-based endotype measures are pending. Further, there was no significant difference in sleep apnea severity or sleep parameters across groups, except stage N2 which was less in current vs former smokers (median-percentage 48.5 vs 66.3%, P&lt;.05) and less in never vs former smokers (61.6 vs 66.3%, P&lt;.05). Conclusion Overall, former vs never smokers appear to be similar with regards to sleep and sleep apnea parameters. Prevalence of current smokers appears to be low (5%) in our cohort; larger sample size and polysomnography-based endotypes are needed before firm conclusions about the effects of smoking on OSA mechanisms can be reached (data collection continues). Support This study had no specific funding. Christopher Schmickl is supported by NIH T32 grant HL134632.

357 Daridorexant Does Not Impair Respiratory Function in Patients with Mild/Moderate Obstructive Sleep Apnea Irrespective of Severity

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A142-A143
Author(s):  
Marie-Laure Boof ◽  
Ingo Fietze ◽  
Katharina Lederer ◽  
Anne-Sophie Guern ◽  
Vincent Lemoine ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Respiratory Function ◽  
Statistical Significance ◽  
Least Square ◽  
Apnea Hypopnea Index ◽  
Peripheral Oxygen Saturation ◽  
Double Blind ◽  
Treatment Difference ◽  
Obstructive Sleep

Abstract Introduction Daridorexant is a dual orexin receptor antagonist developed for the treatment of insomnia. The effect of the highest phase-3 dose of 50 mg daridorexant on nighttime respiratory function was evaluated in patients with mild/moderate obstructive sleep apnea (OSA). This study showed that repeated doses of daridorexant had no clinically meaningful effect on nighttime respiration (i.e., apnea-hypopnea index [AHI] and peripheral oxygen saturation [SpO2]). In the same study, other relevant respiratory endpoints were evaluated. Methods In this randomized, double-blind, placebo-controlled, two-period, crossover study, daridorexant or placebo was administered in each period once daily for 5 consecutive nights to 28 patients. Treatment differences (daridorexant – placebo) for total number and mean/longest duration of apneas and hypopneas as well as mean and lowest SpO2 during apnea/hypopnea events in Night 5 were explored using linear mixed-effects modeling. Treatment differences for the above-mentioned endpoints versus AHI during TST at baseline (i.e., OSA severity) was analyzed by linear regression using least square approach. Results Of 28 patients enrolled, 25 completed the study and were included in the analysis (n=15/10 with mild/moderate OSA; mean [standard deviation, SD] AHI: 16.3 events/h [8.2]). Compared to placebo, daridorexant increased mean duration of TST and accordingly to a not statistically significant extent the mean number of apneas + hypopneas by 16.4 events (n=103 versus 86.2; 90% confidence interval [CI]: -0.4–33.2]) without difference in mean [SD] AHI between daridorexant (15.1 events/h [7.9] and placebo (14.2 [7.7]). No treatment difference was detected for mean (0.0 sec [-2.6–2.7]) or longest (0.8 sec [-8.9–10.5]) duration of apneas nor for mean (0.2 sec [-2.2–2.5]) or longest (8.3 sec [6.4–23.1]) duration of hypopneas. No treatment difference was observed for mean (0.3% [-0.2–2.1]) and lowest (0.9% [0.3–2.1]) SpO2 during apnea/hypopnea events. Treatment differences for any of the evaluated endpoints did not significantly correlate with AHI at baseline as a marker of OSA severity (r2 ≤ 0.09). Conclusion Daridorexant can safely be administered to patients with mild/moderate OSA as treatment differences for respiratory-related endpoints were not of statistical significance and independent of disease severity in the studied population. Support (if any) Funded by Idorsia Pharmaceuticals Ltd.

Sign in / Sign up

Export Citation Format

Share Document