OSA
Conditions
Keywords
Apnea/Hypopnea Index (AHI), Lemborexant, Obstructive Sleep Apnea (OSA), Low Arousal Threshold, Polysomnography
Brief summary
The goal of this randomized, placebo-controlled, double-blind, crossover trial (1-week wash out period) is to compare 1 night of 5 mg Lemborexant to placebo administered before sleep in 10 moderate to severe OSA patients with low arousal threshold The main questions it aims to answer are: 1. The effect of Lemborexant on apnea/hypopnea index (AHI) in moderate-to-severe OSA patients with low arousal threshold. 2. The effect of Lemborexant on the following parameters in moderate-to-severe OSA patients with low arousal threshold. * Arousal threshold * Mean and nadir oxygen saturation * Sleep latency * Sleep efficiency * Wake after sleep onset (WASO) * Percentage of time spent in NREM stage 1-3 and REM stage * Stanford Sleepiness Scale Questionnaire in the morning * The Oxford Sleep Resistance Test (OSLER) test Participants will * complete two overnight in-laboratory polysomnography (1-week washout) * complete the OSLER test in the morning of the two overnight test Researchers will compare with the placebo group to see if there is a difference in AHI
Detailed description
Research Design A randomized, placebo-controlled, double-blind, crossover trial (1-week wash out period) comparing 1 night of 5 mg Lemborexant to placebo administered before sleep. Research Methodology Participants A total of 10 moderate to severe OSA patients with low arousal threshold are randomized 1:1 to either Lemborexant or placebo. The participants will complete two overnight in-laboratory polysomnography (1-week washout). Next-morning alertness will also be assessed using OSLER test, respectively. Inclusion criteria Eligible, healthy individuals with all the followings: * Untreated OSA patient 18 - 65 years of age * AHI ≥15 events/h of sleep * Low arousal threshold Study protocol All patients who were previously diagnosed with moderate to severe obstructive sleep apnea from baseline polysomnography with a low arousal threshold will be enrolled. The patients will be subsequently randomized 1:1 to one of the two treatment sequences. Participants will complete two overnight sleep studies and cross-over with 1-week wash-out period. Patients will receive either Lemborexant 5 mg per day or placebo prior 5 minutes before lights-out. During this 2-night polysomnography, sleep parameters will be analyzed including AHI, mean and nadir oxygen indices, sleep latency, sleep efficiency, wake after sleep onset (WASO), and percentage of time spent in NREM, stage 1-3 and REM stage. The OSLER test to define vigilance will be obtained on the following morning.
Interventions
DRUGLemborexant 5 MG Oral Tablet [Dayvigo] Day 1
Patients will receive Lemborexant 5 mg per day on the first day of sleep test
DRUGLemborexant 5 MG Oral Tablet [Dayvigo] Day 2
Patients will receive Lemborexant 5 mg per day on the second day of sleep test
DRUGPlacebo Day 1
Patients will receive placebo on the first day of sleep test
DRUGPlacebo Day 2
Patients will receive placebo on the second day of sleep test
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
The patients will be subsequently randomized 1:1 to one of the two treatment sequences. Participants will complete two overnight sleep studies and cross-over with 1-week wash-out period. Patients will receive either Lemborexant 5 mg per day or placebo prior 5 minutes before lights-out. Time of lights out was calculated from the median usual bedtime for each participant from the most recent 5 days (± 1 hour) and was kept constant between the two study nights. During this 2-night polysomnography, sleep parameters will be analyzed. The OSLER test to define vigilance will be obtained on the following morning.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Untreated OSA patient 18 - 65 years of age(49) * AHI ≥15 events/h of sleep (moderate to severe)(23, 49) * Low arousal threshold was defined using previously recommended criteria which allocated a score of 1 to each criterion that was satisfied: (apnea-hypopnea index, \<30 events per hour) + (nadir oxygen saturation as measured by pulse oximetry \>82.5%) + (fraction of hypopneas \>58.3%). A score of 2 or above defined a low arousal threshold(50) (low arousal threshold defined as esophageal pressure values are 0 to -15 cmH2O)(27)
Exclusion criteria
* Previous allergy or adverse effects with Lemborexant or other sedatives - Taking any medication that affects sleep or other variable measured in this study - Pregnant or nursing mothers - Respiratory disorders other than OSA - Comorbid disease of poor controlled or resistant hypertension, uncontrolled cardiovascular or cerebrovascular disease * Using CPAP or other dental devices * Unable to tolerate equipment in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| apnea/hypopnea index (AHI) | through study completion, one week | AHI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep latency (Time the patients fall asleep) | through study completion, one week | Time spent from light out to the first 20 consecutive 30-second period of nonwakefulness (minutes) |
| Sleep efficiency (Time the patients actually sleep through out the experiment) | through study completion, one week | Time the patient sleep per time in bed which is the total sleep time per time from light out until light on (total record time (TRT) (8 hours) (minutes) |
| Mean and nadir oxygen saturation | through study completion, one week | — |
| Percentage of time spent in NREM stage 1-3 and REM stage | through study completion, one week | — |
| The Oxford Sleep Resistance Test (OSLER) test | through study completion, one week | — |
| Wake after sleep onset (WASO) | through study completion, one week | Total time of wakefulness after initial sleep onset until light on |
Countries
Thailand
Outcome results
None listed