scholarly journals 0497 Rebound Insomnia During Discontinuation of Chronic Hypnotic Use

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A190-A190
Author(s):  
G Koshorek ◽  
J Verkler ◽  
T Roth ◽  
T Roehrs
Keyword(s):  
Clinical Trial ◽  
Sleep Latency ◽  
Sleep Onset ◽  
Sleep Efficiency ◽  
Study Medication ◽  
Rebound Insomnia ◽  
Dsm V ◽  
Hypnotic Medication ◽  
Choice Period ◽  
Trial Participants

Abstract Introduction Rebound insomnia refers to worsened sleep relative to baseline on 1-2 nights after discontinuation of active hypnotic medication. Rebound is typically assessed using a placebo substitution. We assessed rebound in an on-going “blinded” clinical trial in which people with insomnia are instructed to discontinue their study medication (i.e., no-pill) after 6 months of nightly use. Methods DSM-V diagnosed people with insomnia (n=31, 26 females), aged 26-61 yrs, with a polysomnographic sleep efficiency of ≤85%, no other sleep disorders, unstable medical or psychiatric diseases or drug dependency completed the clinical trial. Participants were randomized to zolpidem XR (12.5 mg), eszopiclone (3 mg) or placebo nightly for 6 months (blinded groups A: n=11, B: n=9, C: n=11). After 6 months, over a 2-week choice period, they were given the instruction to discontinue their nightly hypnotic use with an opportunity, if necessary, to self-administer either 1, 2, or 3 capsules of their assigned medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). On baseline and the14 discontinuation nights, sleep was recorded and scored by actigraphy for sleep efficiency (SE), sleep latency (LAT) and wake after sleep onset (WASO). Results Relative to the baseline night, on the first discontinuation night there was no difference in SE, LAT, and WASO. Fifteen subjects stopped taking study medication when told to discontinue and 16 subjects took study medication on one night or more. While not differing on baseline or night 1, on night 14 the last study night the medication users had a lower SE (75.9 vs 87.7 %, p<.0.004) and a longer LAT (61.5 vs 14.5 min, p<0.05). Conclusion Difficulty discontinuing hypnotic use is not specifically related to rebound insomnia. We reported in a companion abstract those with insomnia and hyperarousal, defined by MSLT, are those with difficulty discontinuing hypnotic use and as shown here slept poorly on the last study night. Support NIDA, grant#: R01DA038177 awarded to Dr. Roehrs

scholarly journals 0492 Sleep and Hyperarousal: Inability to Discontinue Chronic Hypnotic Use

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A188-A189
Author(s):  
T Roehrs ◽  
G Koshorek ◽  
J Verkler ◽  
T Roth
Keyword(s):  
Clinical Trial ◽  
Sleep Latency ◽  
Sleep Onset ◽  
Study Medication ◽  
Nocturnal Sleep ◽  
Urinary Cortisol ◽  
Wake Time ◽  
Dsm V ◽  
Choice Period ◽  
Trial Participants

Abstract Introduction Inability to discontinue chronic hypnotic use by people with insomnia remains a clinical concern. Sleep and hyperarousal was examined in an on-going “blinded” clinical trial in which people with insomnia are instructed to discontinue their study medication after 6 months of nightly use. Methods DSM-V diagnosed people with insomnia (n=31, 26 females), aged 23-61 yrs, with a polysomnographic sleep efficiency (SE) of ≤85% on a 8-hr polysomnogram, no other sleep disorders, unstable medical or psychiatric diseases or drug dependency have completed the clinical trial. Participants were randomized to zolpidem XR (12.5 mg), eszopiclone (3 mg) or placebo nightly for 6 months (blinded groups A: n=11, B: n=9, C: n=11). After 6 months, over a 2-week choice period, they were given the instruction to discontinue their nightly hypnotic use with an opportunity, if necessary, to self-administer either 1, 2, or 3 capsules of their assigned medication (zolpidem XR 6.25 mg as capsule 1, 6.25 mg as capsule 2, placebo as capsule 3; eszopiclone 2 mg, 1 mg, and placebo as capsules 1, 2 and 3 respectively; or 3 placebos. Results Fifteen subjects stopped taking study medication when told to discontinue. The other 16 subjects who took study medication (users) had longer MSLT (a measure of hyperarousal) sleep latency (16.2 vs 8.3 min) than non-users (p<.001) at baseline. At baseline users and non-users had similarly disturbed nocturnal sleep: SE 73.4 vs 73.9 %, with sleep latencies of 54 vs 40 min and wake time after sleep onset of 90 vs 104 min. Conclusion Hyperarousal, defined by MSLT and high diurnal urinary cortisol levels, has been found in some people with insomnia. High MSLTs were previously associated with dose escalation in a chronic zolpidem use study. These emerging data would suggest high MSLT may also be predictive of difficulty discontinuing hypnotic use. Support NIDA, grant#: R01DA038177 awarded to Dr. Roehrs

scholarly journals 0496 Self-Reported Sleep During Discontinuation of Chronic Hypnotic Use

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A190-A190
Author(s):  
J Verkler ◽  
G Koshorek ◽  
T Roth ◽  
T Roehrs
Keyword(s):  
Clinical Trial ◽  
Sleep Quality ◽  
Sleep Latency ◽  
Sleep Onset ◽  
Psychiatric Diseases ◽  
Study Medication ◽  
Dsm V ◽  
Choice Period ◽  
Sleep Questionnaires ◽  
Trial Participants

Abstract Introduction Inability to discontinue chronic hypnotic use by people with insomnia remains a clinical concern. Self-reported sleep in an on-going “blinded” clinical trial in which people with insomnia are instructed to discontinue their study medication after 6 months of nightly use was examined and compared to objective actigraphic recordings of their sleep. Methods DSM-V diagnosed people with insomnia (n=31, 26 females), aged 26-61 yrs, with a polysomnographic sleep efficiency of ≤85%, no other sleep disorders, unstable medical or psychiatric diseases or drug dependency completed the clinical trial. Participants were randomized to zolpidem XR (12.5 mg), eszopiclone (3 mg) or placebo nightly for 6 months (blinded groups A: n=11, B: n=9, C: n=11). After 6 months, over a 2-week choice period, they were given the instruction to discontinue their nightly hypnotic use with an opportunity, if necessary, to self-administer either 1, 2, or 3 capsules of their assigned medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). On post-sleep questionnaires they reported sleep latency (LAT), wake after sleep onset (WASO), and sleep quality (Q:1-5; best - worst). Results 15 subjects stopped taking study medication when told to discontinue. The 16 subjects who took study medication had shorter LAT on nights they took capsules then on nights they did not (31 vs 38 min, p<.03), less WASO (22 vs 44 min, p<.02) and better Q (2.3 vs 3.2, p<.002). In contrast, actigraphic recordings of sleep showed no differences in LAT, WASO, or SE. Conclusion For subjects who took study medication during the nights they were instructed to discontinue, they reported better sleep than on the nights they used no medication, although objectively their sleep did not differ. Support NIDA, grant#: R01DA038177 awarded to Dr. Roehrs

scholarly journals 0494 Ability to Discontinue Chronic Hypnotic Use: An Update

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A189-A189
Author(s):  
T Roth ◽  
G Koshorek ◽  
J Verkler ◽  
T Roehrs
Keyword(s):  
Sleep Efficiency ◽  
Psychiatric Diseases ◽  
Study Medication ◽  
Self Administration ◽  
Disturbed Sleep ◽  
Choice Procedures ◽  
Dsm V ◽  
Choice Period ◽  
Trial Participants ◽  
Chronic Use

Abstract Introduction Physicians prescribing hypnotics remain concerned regarding patient’s inability to discontinue hypnotics after chronic use. That concern has never been directly tested in a controlled prospective study using self-administration choice procedures. This is an update on results from an on-going “blinded” clinical trial in which insomnia subjects are instructed to stop taking their study medication after 6 months of nightly use. Methods DSM-V diagnosed insomnia subjects, aged 23-61 yrs, (n=31, 26 females), with disturbed sleep (i.e., polysomnographic sleep efficiency of ≤85%), no other sleep disorder, unstable medical or psychiatric diseases or drug dependency completed the trial. Participants were randomized to zolpidem XR (12.5 mg), eszopiclone (3 mg), or placebo nightly for 6 months (blinded groups A: n=11, B: n=9, C: n=11). After 6 months, nightly use, over a 2-week choice period, they were instructed to discontinue hypnotic use, but if necessary, to self-administer either 1, 2, or 3 capsules of their assigned medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). Results The number of capsules taken declined from week 1 to 2 (p< .001). Over the 2 weeks 15 participants took 0 (48%), 12 ≤ 6 (39%) and 4 ≥10 total capsules (1 each took 42, 19, 13, and 10). Among those taking capsules, most took one capsule per night and 6 took > 1 capsule. Those 4 taking ≥ 10 were younger (p<.05), but did not differ in screening sleep efficiency or blinded treatment group. Importantly 1 subject took every capsule available. Conclusion The majority (87%) of the participants discontinued 6-month nightly hypnotic use (i.e. took ≤ 6 total capsules) and among those taking capsules the rate declined from week 1 to 2. Age may help identify the few with difficulty discontinuing. Support NIDA, grant#: R01DA038177 awarded to Dr. Roehrs

A Sleep Laboratory Evaluation of the Long-Term Efficacy of Zopiclone

1988 ◽  
Vol 33 (2) ◽  
pp. 103-107 ◽  
Author(s):  
Jonathan A.E. Fleming ◽  
Jean Bourgouin ◽  
Peter Hamilton
Keyword(s):  
Sleep Onset ◽  
Sleep Time ◽  
Sleep Efficiency ◽  
Laboratory Evaluation ◽  
Sleep Study ◽  
Sleep Studies ◽  
Metallic Taste ◽  
Hypnotic Medication ◽  
Drug Free

Six patients between the ages of 25 and 59, with chronic, primary insomnia received the new, non-benzodiazepine, hypnotic zopiclone continuously for 17 weeks after a drug free interval of 12 nights. To qualify for the study, sleep efficiency, determined by a sleep study on two, consecutive, placebo-controlled nights, had to be less than 75%. Patients evaluated their sleep by questionnaire and had sleep studies completed throughout active treatment. Zopiclone (7.5 mg) increased sleep efficiency by decreasing sleep latency, wakefulness after sleep onset and increasing total sleep time. Sleep architecture was minimally affected by zopiclone treatment; no significant changes in delta or REM sleep were observed. The commonest side effect was a bitter or metallic taste. No significant changes in biological functioning were noted throughout the study period. These findings indicate that zopiclone is a safe and effective hypnotic medication which maintains its effectiveness with protracted use.

803 Sleep Disturbances in Patients with Frontotemporal Dementia

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A312-A314
Author(s):  
Nathan Walker ◽  
Bradley Vaughn
Keyword(s):  
Sleep Apnea ◽  
Frontotemporal Dementia ◽  
Rem Sleep ◽  
Sleep Disturbances ◽  
Sleep Latency ◽  
Sleep Onset ◽  
Retrospective Chart Review ◽  
Sleep Efficiency ◽  
Periodic Limb Movements ◽  
Apnea Hypopnea Index

Abstract Introduction Frontotemporal dementia (FTD) is a degenerative process and,as the name implies, involves the frontal and temporal lobes of the brain. Patients with FTD make up 10–15% of all cases of dementia and 20% diagnosed before age 65, however not much is reported about sleep disturbances in these patients. Given the area of neuronal loss one would expect that sleep may be influenced early and by issues in arousal mechanisms and in breathing pattern. This study examined the polysomnography (PSG) reports of patients with a diagnosis FTD. Methods A retrospective chart review was performed to identify patients with both a diagnosis of FTD and having undergone a PSG. 23 patients were identified as fulfilling both requirements. Data recorded included, diagnosis, age at time of PSG, Epworth sleepiness scale (ESS), total sleep time (TST), wake after sleep onset (WASO), sleep latency (SL), REM sleep latency, sleep efficiency (SE), percentage of stage N1, N2, N3, and REM sleep, apnea-hypopnea index (AHI), presence of Cheyne-Stoke breathing, periodic limb movement index, and presence of REM without atonia. Results Patient age ranged from 57–85 years. Average ESS was 8.8 with only 5 patients reported excessive daytime sleepiness(as assessed by ESS). The average TST was 290 minutes, average SL was 37.9 minutes, average WASO was 147.5 minutes, and average sleep efficiency was 60.3%. Patients spent the majority of time in N2 sleep with an average of 68.3% of the time spent in N2. The average time spent in N3 was 9.6% of sleep. 8.9% of sleep was spent in REM. 83% of patients were diagnosed with sleep apnea (as defined by an AHI > 5), with an average AHI of 20.2 events/hour. Cheyne-Stokes breathing was only noted in 4 of the 23 patients, or 17%. Periodic limb movements of sleep were noted in 48% of the patients (n=11). REM without atonia or RBD was not noted for any patients. Conclusion This study shows that patients with FTD suffer from typical sleep disturbances, however there is a high prevalence of sleep apnea as well as PLMS. In addition, patients with FTD have decreased sleep efficiency with increased WASO. Support (if any):

313 Sleep Obtained by Cabin Crewmembers During a Long-haul Flight

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A125-A125
Author(s):  
Lucia Arsintescu ◽  
Cassie Hilditch ◽  
Zachary Glaros ◽  
Kenji Kato ◽  
Kevin Gregory ◽  
...  
Keyword(s):  
Sleep Latency ◽  
Sleep Onset ◽  
Significant Risk ◽  
Sleep Efficiency ◽  
Sleep Diary ◽  
Start Time ◽  
Flight Duration ◽  
Entire Study ◽  
Subsequent Performance ◽  
And Performance

Abstract Introduction Sleep loss and circadian disruption pose a significant risk in safety-sensitive occupations. In aviation, many studies have demonstrated how inflight rest locations influence alertness and performance among pilots, but few studies have evaluated cabin crew. The purpose of the present study was to evaluate sleep outcomes among cabin crewmembers sleeping in a bunk compared to a jump seat during one long-haul route. Methods Thirty-one (6 male) cabin crewmembers (age M = 30, SD = +/-13) flew the same long-haul route (outbound and return) with a flight duration of 10:41 (± 0:14) hours. Participants were randomly assigned to fly on an aircraft with a bunk or a jump seat for their sleep opportunity. Participants wore an Actiwatch (Phillips-Respironics Spectrum) throughout the entire study and completed a sleep diary at bedtime and upon waking. During flight they completed a nap diary entering the start time of the inflight sleep (if any) and the duration. Results Sixty-five flights (32 outbound and 33 return) were included in the analyses. Seventy-seven percent of the flights had a bunk and 23% had a jump seat. Crewmembers obtained M = 146.46 (± 67.20) minutes of rest out of which they slept M = 125.33 (± 64.91) minutes in the bunk. While using the jump seat, crewmembers obtained M = 169.53 (± 133.30) minutes of rest out of which they slept M = 142.92 (± 149.72) minutes. When crewmembers slept in the bunk, sleep latency was shorter (M = 13.69 ± 12.64 minutes) and efficiency was better (M = 76.16 ± 16.09 %) compared to the jump seat (sleep onset: M = 16.77 ± 13.89 minutes; sleep efficiency: M = 60.64 ± 17.42 %). Conclusion We found that cabin crewmembers slept for longer time when they used the jump seat. They fell asleep faster and their sleep efficiency was better when using the bunk compared to the jump seat. Further research is needed to understand how sleep quality and subsequent performance are influenced by sleep opportunity in a bunk compared to a jump seat. Support (if any) NASA Airspace Operations and Safety Program, System-Wide Safety Project.

scholarly journals Nighttime Variability in Wrist Actigraphy

2011 ◽  
Vol 19 (2) ◽  
pp. 105-114 ◽  
Author(s):  
Julie L. Otte ◽  
Judith K. Payne ◽  
Janet S. Carpenter
Keyword(s):  
Repeated Measures ◽  
Sleep Disturbances ◽  
Breast Cancer Survivors ◽  
Sleep Latency ◽  
Sleep Onset ◽  
Sleep Time ◽  
Sleep Efficiency ◽  
Sleep Diary ◽  
Repeated Measures Design ◽  
Wrist Actigraphy

Wrist actigraphy measures sleep activity and circadian rhythm. This study examined nighttime variability in Actiwatch parameters in a sample of breast cancer survivors (BCSs) to determine a minimum number of nights needed to obtain an accurate picture of objective sleep. A descriptive, quantitative, and repeated measures design was used. Consenting participants wore an actigraph and completed a sleep diary across 7 nights. There were no significant differences in wake after sleep onset (WASO), total sleep time (TST), sleep latency, or sleep disturbances across nights of week (Monday to Sunday) or monitoring nights (1st to 7th). Sleep efficiency was significantly better at Night 6 compared with Night 7. The coefficients of variation (CVs) for WASO ranged from 46% to 86%, TST 23%–34%, sleep latency 154%–246%, sleep efficiency 12%–22%, and sleep disturbances 33%–41%. Although the CVs indicated high variability across women, there was little internight variability in WASO or TST during across 7 nights of sleep. This suggests that in BCSs, Actiwatch data could be collected and evaluated from any single night for an accurate measure of usual sleep.

scholarly journals Assessing an Electronic Health Record research platform for identification of clinical trial participants

2021 ◽  
Vol 21 ◽  
pp. 100692
Author(s):  
Niina Laaksonen ◽  
Juha-Matti Varjonen ◽  
Minna Blomster ◽  
Antti Palomäki ◽  
Tuija Vasankari ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Electronic Health Record ◽  
Health Record ◽  
Research Platform ◽  
Electronic Health ◽  
Trial Participants

Mindfulness and Behaviour Therapy for Insomnia: An Assessment of Treatment Effect in a Sleep Disorders Clinic Population with Insomnia

2020 ◽  
pp. 1-15
Author(s):  
Allie Peters ◽  
John Reece ◽  
Hailey Meaklim ◽  
Moira Junge ◽  
David Cunnington ◽  
...  
Keyword(s):  
Sleep Disorders ◽  
Treatment Effect ◽  
Sleep Onset ◽  
Sleep Efficiency ◽  
Health Concern ◽  
Sleep Diary ◽  
Sleep Onset Latency ◽  
Subjective Sleep ◽  
Sleep Parameters

Abstract Insomnia is a common major health concern, which causes significant distress and disruption in a person's life. The objective of this paper was to evaluate a 6-week version of Mindfulness-Based Therapy for Insomnia (MBTI) in a sample of people attending a sleep disorders clinic with insomnia, including those with comorbidities. Thirty participants who met the DSM-IV-TR diagnosis of insomnia participated in a 6-week group intervention. Outcome measures were a daily sleep diary and actigraphy during pre-treatment and follow-up, along with subjective sleep outcomes collected at baseline, end-of-treatment, and 3-month follow-up. Trend analyses showed that MBTI was associated with a large decrease in insomnia severity (p < .001), with indications of maintenance of treatment effect. There were significant improvements in objective sleep parameters, including sleep onset latency (p = .005), sleep efficiency (p = .033), and wake after sleep onset (p = .018). Significant improvements in subjective sleep parameters were also observed for sleep efficiency (p = .005) and wake after sleep onset (p < .001). Overall, this study indicated that MBTI can be successfully delivered in a sleep disorders clinic environment, with evidence of treatment effect for both objective and subjective measures of sleep.

scholarly journals Current challenges and opportunities for pharmacogenomics: perspective of the Industry Pharmacogenomics Working Group (I-PWG)

2021 ◽  
Author(s):  
Karina Bienfait ◽  
Aparna Chhibber ◽  
Jean-Claude Marshall ◽  
Martin Armstrong ◽  
Charles Cox ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Working Group ◽  
Direct Sequencing ◽  
Risk Scores ◽  
Pharmaceutical Companies ◽  
Patient Privacy ◽  
Clinical Implementation ◽  
Genomic Databases ◽  
Group I ◽  
Trial Participants

AbstractPharmaceutical companies have increasingly utilized genomic data for the selection of drug targets and the development of precision medicine approaches. Most major pharmaceutical companies routinely collect DNA from clinical trial participants and conduct pharmacogenomic (PGx) studies. However, the implementation of PGx studies during clinical development presents a number of challenges. These challenges include adapting to a constantly changing global regulatory environment, challenges in study design and clinical implementation, and the increasing concerns over patient privacy. Advances in the field of genomics are also providing new opportunities for pharmaceutical companies, including the availability of large genomic databases linked to patient health information, the growing use of polygenic risk scores, and the direct sequencing of clinical trial participants. The Industry Pharmacogenomics Working Group (I-PWG) is an association of pharmaceutical companies actively working in the field of pharmacogenomics. This I-PWG perspective will provide an overview of the steps pharmaceutical companies are taking to address each of these challenges, and the approaches being taken to capitalize on emerging scientific opportunities.

Sign in / Sign up

Export Citation Format

Share Document