The Optimal One-Month Dosing of Lemborexant for Moderate Obstructive Sleep Apnea (OSA) Patients With Low Arousal Threshold
A legfontosabb adatok
- Ki végzi
- Chulalongkorn University
- Hol
- Pathum Wan (Thaiföld)A helyszín megnézése
- Azonosító
- Állapot
- Toborzás még nem indult
- Fázis
- 1/2. fázis
- Résztvevők
- 36 fő, tervezett
- Kezdés
- 2026. szept. 1.
- Várható befejezés
- 2028. jún. 30.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
- A vizsgált kezelések
- Lemborexant 5 MG [Dayvigo] Period 1
- Placebo Period 1
- Lemborexant 5 MG [Dayvigo] Period 2
- Placebo Period 2
- Lemborexant 5 MG [Dayvigo] Period 3
- Placebo Period 3
- Lemborexant 10 MG [Dayvigo] Period 1
- Lemborexant 10 MG [Dayvigo] Period 2
- Lemborexant 10 MG [Dayvigo] Period 3
- A regiszteradat frissítve
- 2026. július 6.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for adults with moderate obstructive sleep apnea (breathing stops during sleep) who wake up easily from breathing events (low arousal threshold). They will take lemborexant 5 mg, lemborexant 10 mg and placebo, each for 30 days.
- Életkor
- 18 to 65 years
- Nem
- All sexes
- A betegség stádiuma
- Moderate OSA: apnea-hypopnea index 15 - 30 events/h of sleep on a screening sleep study. Low arousal threshold, with a score of 2 or above. SpO2 (blood oxygen) ≥ 94% at screening. Sleeps ≥ 5.5 hours/night, with bedtime between 9:00 PM and 1:00 AM. Body mass index 18 - 40 kg/m2.
- Korábbi kezelés
- People cannot join if they used CPAP or dental devices within 2 weeks of the screening sleep study. They must also not use them until the end of the study.
A részvétel fő kizáró okai
- Allergy or bad reactions to lemborexant or other sleep-inducing drugs
- Pregnant or breastfeeding
- Other sleep disorders, severe daytime sleepiness (ESS ≥16), or central breathing events >25% of total AHI
- Uncontrolled heart or brain blood vessel disease, nerve-muscle disease, other active lung or breathing disorders, or serious mental health conditions
- A sleepiness-related driving accident or near miss in the past 12 months, a safety-critical job, drugs that affect sleep or CYP3A, or drug or alcohol problems
A regiszter feltételei, szó szerint
Mind a 29 feltétel megnézéseKevesebb
Ki vehet részt
- Individuals are eligible for participation in this study if they have all of the followings:
- Patient, aged 18 - 65 years at the time of informed consent
- Voluntary agreement and capable for giving written informed consent
- Diagnosis with OSA according to the criteria of the International Classification of Sleep Disorders, version 3 Text Revision
- Baseline screening polysomnography (PSG) demonstrated apnea-hypopnea index 15 - 30 events/h of sleep (moderate severity)
- Patients identified as low arousal threshold using previously recommended criteria which allocated a score of 1 to each criterion: apnea-hypopnea index < 30 events per hour, nadir oxygen saturation as measured by pulse oximetry > 82.5%, and fraction of hypopneas > 58.3%. A score of 2 or above defined a low arousal threshold
- Peripheral capillary oxygen saturation (SpO2) ≥ 94% measured during screening visit
- Habitually sleeping ≥ 5.5 hours/night with usual bedtime falls within the range of 9:00 PM to 1:00 AM
- Body mass index 18 - 40 kg/m2 Exclusion criteria; Individuals were not eligible for participation in this study if they have any of the followings:
- Previous allergy or adverse effects with Lemborexant or other sedatives
- Pregnant or breastfeeding
- Significant medical comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion
- Uncontrolled cardiovascular or cerebrovascular diseases
- Neuromuscular diseases
- Nasal anatomical defect
- Significant psychiatric comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion
- Active respiratory disorders other than OSA
- Central respiratory events (CAHI) >25% of the total AHI
- Diagnosis/symptoms of sleep-related disease other than OSA including narcolepsy, restless legs syndrome, periodic limb movement disorder, or circadian rhythm sleep-wake disorder
- Severe hypersomnolence (ESS ≥16)
- Peripheral capillary oxygen saturation (SpO2) < 80% for ≥ 5% of total sleep time measured during screening visit
- Driving-related sleepiness accident or near misses in the past 12 months
- Safety-critical occupation
- Using CPAP or other dental devices within 2 weeks of screening polysomnography until the end of the study
- Unable to tolerate equipment in this study
- Taking any medication that affects sleep or other variable measured in this study
- Taking any medication with cytochrome P450 Family 3A (CYP3A) inhibitors and all CYP3A inducers
- Drug or alcohol use disorder within 2 years before the study initiation or current excessive alcohol intake
- Excessive caffeine intake
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 65 év között vagy?
Helyszínek itt: Thaiföld
- Chulalongkorn UniversityPathum Wan, ThaiföldContact: Sarocha Vivatvakin, MDToborzás még nem indult
A vizsgálatról
Mit akar kideríteni a vizsgálat
The goal of this clinical trial is to investigate the 1-month treatment effects of different dose of lemborexant in moderate OSA adult patients (18-65 years of age) with low arousal threshold.
A teljes eredeti leírásKevesebb
The main questions it aims to answer are:
Primary outcome measure: Apnea/hypopnea index (AHI)
Secondary outcome measure:
1. Polysomnography parameters
* Mean and nadir oxygen saturation * Sleep efficiency * Wake after sleep onset (WASO) * Sleep latency * Rapid eye movement (REM) latency * Percentage of time spent in Non-rapid eye movement (NREM) stage 1-3 and REM stage * Arousal index 2. Oxford Sleep Resistance Test (OSLER) test 3. Epworth Sleepiness Scale (ESS) 4. Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T) 5. Pittsburgh Sleep Quality Index (PSQI) 6. Actigraphy parameters
* Total sleep time * Sleep efficiency * Wake after sleep onset (WASO) * Sleep latency 7. Sleep diary parameters (Appendix 5)
* Total sleep time * Sleep efficiency * Wake after sleep onset (WASO) * Sleep latency * Sleep quality
Researchers will compare placebo to see if there is a difference in AHI.
Participants will
* participate a total of 3 phases of study (3-crossover trial) * each phrase the participants will receive either lemborexant 5 mg, lemborexant 10 mg, or placebo orally per day for 30 days with 2-week washout (depend on intervention arm whether the participants receive which intervention sequence) * complete three overnight in-laboratory polysomnography (2-week washout) at day 30 of each phrase * monitor actigraphy during day 1 to 29 of intervention of all periods * record sleep diary during day 1 to 29 of intervention of all periods * complete the OSLER test in the morning of the three overnight test * complete questionnaires including: Epworth Sleepiness Scale (ESS), Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T), Pittsburgh Sleep Quality Index (PSQI) at baseline (prior to intervention) and the night before overnight in-laboratory polysomnography
A vizsgálat 3 csoportja
- Lemborexant 5 mgA vizsgált kezelés
Participants will receive two treatment sequences. Participants will complete three overnight sleep studies and cross-over with 2-week wash-out period The participants will receive lemborexant 5 mg per day before sleep for a total of 30 days. On the day 30 participants will receive the lemborexant 5 mg 5 minutes before lights-out at the sleep laboratory for overnight polysomnography. After 2 week wash-out period, the participants will cross to the placebo or lemborexant 10 mg arm with same repeat of another 2 phases.
Kezelés: Lemborexant 5 MG [Dayvigo] Period 1, Lemborexant 5 MG [Dayvigo] Period 2 és Lemborexant 5 MG [Dayvigo] Period 3
- PlaceboPlacebo, összehasonlításként
Participants will receive two treatment sequences. Participants will complete three overnight sleep studies and cross-over with 2-week wash-out period The participants will receive placebo per day before sleep for a total of 30 days. On the day 30 participants will receive the placebo 5 minutes before lights-out at the sleep laboratory for overnight polysomnography. After 2 week wash-out period, the participants will cross to the lemborexant 5 or 10 mg arm with same repeat of another 2 phases.
Kezelés: Placebo Period 1, Placebo Period 2 és Placebo Period 3
- Lemborexant 10 mgA vizsgált kezelés
Participants will receive two treatment sequences. Participants will complete three overnight sleep studies and cross-over with 2-week wash-out period The participants will receive lemborexant 10 mg per day before sleep for a total of 30 days. On the day 30 participants will receive the lemborexant 10 mg 5 minutes before lights-out at the sleep laboratory for overnight polysomnography. After 2 week wash-out period, the participants will cross to the placebo or lemborexant 5 mg arm with same repeat of another 2 phases.
Kezelés: Lemborexant 10 MG [Dayvigo] Period 1, Lemborexant 10 MG [Dayvigo] Period 2 és Lemborexant 10 MG [Dayvigo] Period 3
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- One-Month Dosing of Lemborexant for Treatment of Moderate OSA Patients With Low Arousal Threshold, a Randomized, Double-blind, Crossover, Placebo-Controlled Trial
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- Illeszkedési kérdések
- Forrás: NCT07683442: ki vehet részt
- A regiszteradat frissítve
- 2026. július 6.