scholarly journals P119 CPAP and adverse cardiovascular events in OSA: Are participants of randomized trials representative of sleep clinic patients?

2021 ◽  
Vol 2 (Supplement_1) ◽  
pp. A60-A60
Author(s):  
A Reynor ◽  
N McArdle ◽  
B Shenoy ◽  
S Dhaliwal ◽  
S Rea ◽  
...  
Keyword(s):  
Selection Criteria ◽  
No Reduction ◽  
Randomized Study ◽  
Tertiary Hospital ◽  
Apnea Hypopnea Index ◽  
Disease Symptoms ◽  
Randomized Controlled ◽  
Excessive Sleepiness ◽  
Obstructive Sleep ◽  
Cv Disease

Abstract Introduction Randomized controlled trials (RCTs) have shown no reduction in adverse cardiovascular (CV) events in patients randomized to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA). This study examined whether randomized study populations were representative of OSA patients attending a sleep clinic. Methods Sleep clinic patients were 3,965 consecutive adults diagnosed with OSA by in-laboratory polysomnography from 2006–2010 at a tertiary hospital sleep clinic. Characteristics of these sleep clinic OSA patients were compared with participants of 5 well-known RCTs examining the effect of CPAP on adverse CV events in OSA. We determined the percentage of patients with severe (apnea hypopnea index, [AHI]≥30/h) or any OSA (AHI≥5/h) who met the selection criteria of each RCT, as well as identified those criteria that excluded the most patients. Results Compared to RCT participants, sleep clinic OSA patients were younger, sleepier, more likely to be female and less likely to have established CV disease. The percentage of patients with severe or any OSA who met the RCT selection criteria ranged from 1.2% to 20.2% and 0.8% to 21.1%, respectively. The selection criteria that excluded most patients were pre-existing CV disease, symptoms of excessive sleepiness, nocturnal hypoxemia and co-morbidities. Discussion A minority of sleep clinic patients diagnosed with OSA meet the selection criteria of RCTs of CPAP on adverse CV events in OSA. OSA populations in RCTs differ considerably from typical sleep clinic OSA patients. This suggests that the findings of RCTs may not be generalisable to most sleep clinic OSA patients.

Continuous positive airway pressure and adverse cardiovascular events in obstructive sleep apnea: Are participants of randomized trials representative of sleep clinic patients?

SLEEP ◽  
2021 ◽  
Author(s):  
Ayesha Reynor ◽  
Nigel McArdle ◽  
Bindiya Shenoy ◽  
Satvinder S Dhaliwal ◽  
Siobhan C Rea ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Continuous Positive Airway Pressure ◽  
Airway Pressure ◽  
Positive Airway Pressure ◽  
Randomized Study ◽  
Apnea Hypopnea Index ◽  
Eligibility Criteria ◽  
Obstructive Sleep ◽  
Cv Disease

Abstract Study Objectives Randomized controlled trials (RCTs) have shown no reduction in adverse cardiovascular (CV) events in patients randomized to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA). This study examined whether randomized study populations were representative of OSA patients attending a sleep clinic. Methods Sleep clinic patients were 3,965 consecutive adults diagnosed with OSA by in-laboratory polysomnography from 2006-2010 at a tertiary hospital sleep clinic. Characteristics of these patients were compared with participants of 5 recent RCTs examining the effect of CPAP on adverse CV events in OSA. The percentage of patients with severe (apnea hypopnea index, [AHI]≥30 events/hour) or any OSA (AHI≥5 events/hour) who met the eligibility criteria of each RCT was determined, and those criteria that excluded the most patients identified. Results Compared to RCT participants, sleep clinic OSA patients were younger, sleepier, more likely to be female and less likely to have established CV disease. The percentage of patients with severe or any OSA who met the RCT eligibility criteria ranged from 1.2% to 20.9% and 0.8% to 21.9%, respectively. The eligibility criteria that excluded most patients were pre-existing CV disease, symptoms of excessive sleepiness, nocturnal hypoxemia and co-morbidities. Conclusions A minority of sleep clinic patients diagnosed with OSA meet the eligibility criteria of RCTs of CPAP on adverse CV events in OSA. OSA populations in these RCTs differ considerably from typical sleep clinic OSA patients. This suggests that the findings of such OSA treatment-related RCTs are not generalisable to sleep clinic OSA patients.

scholarly journals Comparison of Auto- and Fixed-Continuous Positive Airway Pressure on Air Leak in Patients with Obstructive Sleep Apnea: Data from a Randomized Controlled Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-7
Author(s):  
Marius Lebret ◽  
Marie-Caroline Rotty ◽  
Cyril Argento ◽  
Jean-Louis Pepin ◽  
Renaud Tamisier ◽  
...  
Keyword(s):  
Positive Airway Pressure ◽  
Controlled Trial ◽  
Univariate Analysis ◽  
Tobacco Consumption ◽  
Apnea Hypopnea Index ◽  
Newly Diagnosed ◽  
Air Leak ◽  
Double Blind ◽  
Randomized Controlled ◽  
Obstructive Sleep

Auto-CPAP may cause sleep fragmentation due to variations in pressure and unintentional leaks. The aim of this study was to compare air leak between fixed-CPAP and auto-CPAP after 4 months of CPAP treatment. This study is an ancillary analysis of a randomized, double-blind, parallel, controlled trial over 4 months, comparing fixed- and auto-CPAP in newly diagnosed patients with OSA. The following data were extracted from the CPAP devices: mean and 90th percentile pressure, residual apnea-hypopnea index, mean CPAP use, and amount of leak. Within each arm, patients were also randomly allocated to use of one of the three different brands of devices. Since the leak was reported differently for each device, median leak value was determined for each brand and leaks were classified as “above the median” or “below the median”. Data from 269 patients were analyzed. The univariate analysis showed that tobacco consumption, CPAP level, and oronasal masks were associated with leaks above the median value but not the type of CPAP. The multivariate analysis showed that only CPAP level and oronasal masks were associated with leaks below the median. There were no differences in the types of mask used between fixed- and auto-CPAP. There was no impact of the type of CPAP on leaks or the type of interface used. We used a method based on the median leak value to standardize comparisons across devices which report leaks with different definitions.

Robotic Modification of Epiglottis Trimming in the Treatment of Obstructive Sleep Apnea

2021 ◽  
pp. 019459982110646
Author(s):  
Mehmet Ali Babademez ◽  
Fatih Gul ◽  
Kadir Sinasi Bulut ◽  
Mecit Sancak ◽  
Saliha Kusoglu Atalay
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Tertiary Hospital ◽  
Apnea Hypopnea Index ◽  
Complete Relief ◽  
Sleep Endoscopy ◽  
Drug Induced ◽  
Drug Induced Sleep Endoscopy ◽  
Obstructive Sleep ◽  
Significant Difference

Objective With the widespread use of drug-induced sleep endoscopy, it has been suggested that epiglottis pathologies are present at high rates in patients with sleep apnea. The aim of our study was to evaluate the efficacy of trimming the curled-inward epiglottis as an updated surgical technique in patients with omega epiglottis. Study Design Retrospective study. Setting Tertiary hospital. Methods Among the 283 patients with epiglottis pathology, 21 with isolated omega-shaped epiglottis (age, 33-53 years) fulfilled the inclusion criteria between May 2016 and April 2019. Drug-induced sleep endoscopy was used to detect epiglottic collapse compressed by the lateral parts during inspiration. An epiglottoplasty technique was applied as single-level sleep surgery in patients with an isolated omega-shaped epiglottis. The medical data were also reviewed. Results The mean pre- and postoperative total apnea-hypopnea index (AHI) scores were 27.89 and 10.58, respectively, and this difference was statistically significant ( P < .001). There was a statistically significant difference between the pre- and postoperative supine AHI scores (27.02 vs 10.48, P < .001). Surgical success, defined as AHI <20 and a decrease in AHI by 50%, was documented in 85.71% of patients (18/21), and 12 patients found complete relief from obstructive sleep apnea symptoms (AHI <5); the cure rate was 38.09% (8/21). Conclusion Trimming the curled-inward epiglottis may represent an excellent option for epiglottis surgery in patients with obstructive sleep apnea by being less invasive than techniques currently in use.

Abstract 2462: Obstructive Sleep Apnea Treatment Improves the Blood Pressure Behavior in Normotensive Patients: A Randomized Study

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Luciano F Drager ◽  
Patrícia M Diniz ◽  
Luzia Diegues-Silva ◽  
Roberta B Couto ◽  
Rodrigo P Pedrosa ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Randomized Study ◽  
Control Group ◽  
Apnea Hypopnea Index ◽  
Obstructive Sleep ◽  
The Impact ◽  
Current Guidelines ◽  
Concomitant Hypertension

Introduction: Obstructive sleep apnea (OSA) promotes significant alterations on blood pressure during sleep. In patients with concomitant hypertension, the treatment with continuous positive airway pressure (CPAP) promotes significant reductions on blood pressure. However, the impact of CPAP on 24 hour blood pressure in normotensive patients is poorly understood. Methods: We included 22 apparently healthy patients with severe OSA defined by polysomnography (apnea/hypopnea index (AHI) >30 events/hour). We excluded hypertension according current guidelines by office measurements. They were randomized to no treatment (control) or CPAP for 3 months. At baseline and at the end of the protocol, we performed 24 hour blood pressure (BP) monitoring evaluating daytime and nighttime BP as well as the morning surge (average of systolic BP during the 2 hours after awakening minus the average of systolic BP during the 1 hour that included the lowest nighttime BP) and highest systolic nighttime BP (mean of 3 BP measurements, centered on the highest nighttime reading). Results: After 3 months, patients randomized to CPAP (mean CPAP usage: 6 hours) presented a significant reduction on daytime (80.3±6.3 to 75.3±6.9 mmHg; P=0.02) and nighttime diastolic BP (67.8±9.5 to 61.4±7.5 mmHg; P=0.03). In addition, we observed a significant reduction on highest nighttime systolic BP (120.0±13.6 to 112.0±.9 mmHg; P=0.02) with a trend for a reduction on morning surge (22.3±9.2 to 17.3±.4 mmHg; P=0.08). No significant alterations occurred in the control group. Conclusion: Even in the absence of established hypertension, CPAP therapy improved the behavior of 24 hour BP in patients with severe OSA.

scholarly journals Comparative Evaluation Of The Efficacy Of Customized Maxillary Oral Appliance With Mandibular Advancement Appliance As A Treatment Modality For Moderate Obstructive Sleep Apnea Patients- Protocol For A Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Vikram Murlidhar Belkhode ◽  
Surekha Godbole ◽  
Sharayu Vinod Nimonkar
Keyword(s):  
Randomized Controlled Trial ◽  
Pressure Transducer ◽  
Controlled Trial ◽  
Oral Appliance ◽  
Mandibular Advancement Device ◽  
Mandibular Advancement ◽  
Apnea Hypopnea Index ◽  
Nasal Airflow ◽  
Randomized Controlled ◽  
Obstructive Sleep

BACKGROUND Obstructive sleep apnea (OSA) is due to the obstruction of the upper airway during sleep. This condition is often associated with multiple symptoms and co-morbidities. There are many treatment options mentioned in the literature to manage OSA, among which interventional option of continuous positive airflow (CPAP) and non-interventional option i.e, Mandibular advancement device (MAD), which is an oral appliance (OA) are most preferred ones. OBJECTIVE To evaluate the efficacy of customized maxillary Oral appliance compared with mandibular advancement device in moderate OSA patients. METHODS A Prospective Interventional study with a randomized controlled trial will be carried out involving 40 participants (sample size), with an apnea-hypopnea index (AHI) >15–30, recorded on Polysomnography (PSG). Study participants will be randomly divided into following treatment groups: control group or group subjected to mandibular advancement device (MAD, n=20) and second group subjected to customized maxillary oral appliance (CMOA, n=20). Baseline assessment of Apnea/hypopnea index (AHI), oxygen saturation in blood, percentage of rapid eye movement, electroencephalogram, electrocardiogram, oro-nasal airflow via a pressure transducer, and Epworth sleepiness scale will be done. Then both study group participants will receive their respective appliances. And after one month and three months of delivery of appliance, all the parameters i.e AHI, oxygen saturation in blood, percentage of rapid eye movement, electroencephalogram, electrocardiogram, oro-nasal airflow via a pressure transducer, and Epworth sleepiness scale will be re-evaluated and compared with the baseline measurements. RESULTS Descriptive and analytical statistics will be done. SPSS (Statistical Package for Social Sciences) Version 20.1 will be used as statistical software. The statistical significance between the two groups after one month and three months will be evaluated at p<0.05. We expect, customized maxillary oral appliance to be more efficient in managing moderate OSA, in comparison with MAD. CONCLUSIONS If the hypothesis of the present study is confirmed, then this customized maxillary appliance will be quoted as a “gold standard” for managing moderate OSA.

scholarly journals Effect of respiratory therapy on patients with sleep bruxism and associated respiratory events: Study protocol for a randomized controlled clinical trial

2021 ◽  
Vol 10 (9) ◽  
pp. e53010918567
Author(s):  
Bianca Lopes Cavalcante-Leão ◽  
José Stechman-Neto ◽  
Glória Cortz Ravazzi ◽  
Anne Elise Sarraff Fischer ◽  
Yasmin Abdula ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sleep Apnea ◽  
Sleep Apnea Syndrome ◽  
Sleep Bruxism ◽  
Respiratory Muscle Training ◽  
Apnea Hypopnea Index ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Respiratory Events ◽  
Obstructive Sleep

Aim: The aim of this study will be to perform respiratory physiotherapy on patients with sleep bruxism and associated respiratory events (apnea and hypopnea). Methodology: The study will be a randomized, controlled, double-blind, clinical trial with a sample of individuals with sleep bruxism and associated respiratory events. Respiratory (inspiratory and/or expiratory) physiotherapy will be performed using the THRESHOLD IMT and PEP and the results will be compared to a placebo group. Discussion: Regarding respiratory events, there is a broad variety of possible treatments for sleep apnea depending on the physiopathology, severity and patient preference, with CPAP considered the gold standard. However, data on CPAP are inconsistent, with adherence to therapy reported to be between 45 and 89%. Thus, other forms of treatment are proposed, including respiratory training. Understanding obstructive sleep apnea syndrome as the loss of the dilation strength of the pharynx and the inability to maintain the path open for air, respiratory muscle training could assist in increasing dilation strength, enabling the passage of air during sleep. Taking into consideration that sleep bruxism may be associated with events of apnea and hypopnea, the intervention to treat obstructive respiratory events related to sleep may have a positive impact on events related to sleep bruxism (rhythmic activity of the masticatory muscles). To determine this, we will measure the apnea/hypopnea index (AHI) and number of contractions of the masseter muscle (characteristic of the activity of bruxism) before and after the intervention using polysomnography. Trial registration: The trial was registered with the REBEC platform: RBR-9F6JKM (ensaiosclinicos.gov.br).

scholarly journals Effect of Upper Airway Stimulation in Patients with Obstructive Sleep Apnea (EFFECT): A Randomized Controlled Crossover Trial

2021 ◽  
Vol 10 (13) ◽  
pp. 2880
Author(s):  
Clemens Heiser ◽  
Armin Steffen ◽  
Benedikt Hofauer ◽  
Reena Mehra ◽  
Patrick J. Strollo ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Crossover Trial ◽  
Upper Airway ◽  
Apnea Hypopnea Index ◽  
Upper Airway Stimulation ◽  
Sham Stimulation ◽  
Randomized Controlled ◽  
Obstructive Sleep ◽  
Significant Difference

Background: Several single-arm prospective studies have demonstrated the safety and effectiveness of upper airway stimulation (UAS) for obstructive sleep apnea. There is limited evidence from randomized, controlled trials of the therapy benefit in terms of OSA burden and its symptoms. Methods: We conducted a multicenter, double-blinded, randomized, sham-controlled, crossover trial to examine the effect of therapeutic stimulation (Stim) versus sham stimulation (Sham) on the apnea-hypopnea index (AHI) and the Epworth Sleepiness Scale (ESS). We also examined the Functional Outcomes of Sleep Questionnaire (FOSQ) on sleep architecture. We analyzed crossover outcome measures after two weeks using repeated measures models controlling for treatment order. Results: The study randomized 89 participants 1:1 to Stim (45) versus Sham (44). After one week, the AHI response rate was 76.7% with Stim and 29.5% with Sham, a difference of 47.2% (95% CI: 24.4 to 64.9, p < 0.001) between the two groups. Similarly, ESS was 7.5 ± 4.9 with Stim and 12.0 ± 4.3 with Sham, with a significant difference of 4.6 (95% CI: 3.1 to 6.1) between the two groups. The crossover phase showed no carryover effect. Among 86 participants who completed both phases, the treatment difference between Stim vs. Sham for AHI was −15.5 (95% CI −18.3 to −12.8), for ESS it was −3.3 (95% CI −4.4 to −2.2), and for FOSQ it was 2.1 (95% CI 1.4 to 2.8). UAS effectively treated both REM and NREM sleep disordered breathing. Conclusions: In comparison with sham stimulation, therapeutic UAS reduced OSA severity, sleepiness symptoms, and improved quality of life among participants with moderate-to-severe OSA.

scholarly journals The Clinical Effect of Acupuncture in the Treatment of Obstructive Sleep Apnea: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2016 ◽  
Vol 2016 ◽  
pp. 1-10 ◽  
Author(s):  
Zheng-tao Lv ◽  
Wen-xiu Jiang ◽  
Jun-ming Huang ◽  
Jin-ming Zhang ◽  
An-min Chen
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Acupuncture Therapy ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Apnea Hypopnea Index ◽  
Controlled Trials ◽  
Control Groups ◽  
Randomized Controlled ◽  
Obstructive Sleep

Purpose.This study aims to determine the clinical efficacy of acupuncture therapy in the treatment of obstructive sleep apnea.Methods.A systematic literature search was conducted in five databases including PubMed, EMBASE, CENTRAL, Wanfang, and CNKI to identify randomized controlled trials (RCTs) on the effect of acupuncture therapy for obstructive sleep apnea. Meta-analysis was conducted using the RevMan version 5.3 software.Results.Six RCTs involving 362 subjects were included in our study. Compared with control groups, manual acupuncture (MA) was more effective in the improvement of apnea/hypopnea index (AHI), apnea index, hypopnea index, and mean SaO2. Electroacupuncture (EA) was better in improving the AHI and apnea index when compared with control treatment, but no statistically significant differences in hypopnea index and mean SaO2were found. In the comparison of MA and nasal continuous positive airway pressure, the results favored MA in the improvement of AHI; there was no statistical difference in the improvement in mean SaO2. No adverse events associated with acupuncture therapy were documented.Conclusion.Compared to control groups, both MA and EA were more effective in improving AHI and mean SaO2. In addition, MA could further improve apnea index and hypopnea index compared to control.

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