The Optimal One-Month Dosing of Lemborexant for Moderate Obstructive Sleep Apnea (OSA) Patients With Low Arousal Threshold (LMOSALAT)
2 de julho de 2026 atualizado por: Chulalongkorn University
One-Month Dosing of Lemborexant for Treatment of Moderate OSA Patients With Low Arousal Threshold, a Randomized, Double-blind, Crossover, Placebo-Controlled Trial
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.
The main questions it aims to answer are:
Primary outcome measure: Apnea/hypopnea index (AHI)
Secondary outcome measure:
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
- Oxford Sleep Resistance Test (OSLER) test
- Epworth Sleepiness Scale (ESS)
- Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T)
- Pittsburgh Sleep Quality Index (PSQI)
Actigraphy parameters
- Total sleep time
- Sleep efficiency
- Wake after sleep onset (WASO)
- Sleep latency
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
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
- Medicamento: Lemborexant 5 MG [Dayvigo] Period 1
- Medicamento: Lemborexant 5 MG [Dayvigo] Period 2
- Medicamento: Lemborexant 5 MG [Dayvigo] Period 3
- Medicamento: Placebo Period 1
- Medicamento: Placebo Period 2
- Medicamento: Placebo Period 3
- Medicamento: Lemborexant 10 MG [Dayvigo] Period 1
- Medicamento: Lemborexant 10 MG [Dayvigo] Period 2
- Medicamento: Lemborexant 10 MG [Dayvigo] Period 3
Tipo de estudo
Intervencional
Inscrição (Estimado)
36
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Sarocha Vivatvakin, MD
- Número de telefone: 66879310233
- E-mail: sarocha.v@chula.ac.th
Estude backup de contato
- Nome: Naricha Chirakalwasan, MD
- Número de telefone: 662-649-4037
- E-mail: narichac@hotmail.com
Locais de estudo
-
-
Bangkok
-
Pathum Wan, Bangkok, Tailândia, 10330
- Chulalongkorn University
-
Contato:
- Sarocha Vivatvakin, MD
- Número de telefone: 66879310233
- E-mail: sarocha.v@chula.ac.th
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion criteria
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Lemborexant 5 mg
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.
|
Participants will receive lemborexant 5 mg per day for 30 days during first period
Participant will receive lemborexant 5 mg per day for 30 days during the second period
Participants will receive lemborexant 5 mg per day for 30 days during third period
|
|
Comparador de Placebo: Placebo
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.
|
Participants will receive placebo 5 mg per day for 30 days during the first period
Participant will receive placebo 5 mg per day for 30 days during the second period
Participants will receive placebo per day for 30 days during third period
|
|
Experimental: Lemborexant 10 mg
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.
|
Participants will receive lemborexant 10 mg per day for 30 days during first period
Participants will receive lemborexant 10 mg per day for 30 days during second period
Participants will receive lemborexant 10 mg per day for 30 days during third period
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Apnea/hypopnea index (AHI)
Prazo: At day 30 during the overnight in-laboratory of each study period
|
Apnea/hypopnea index (AHI) measured by polysomnography (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome)
|
At day 30 during the overnight in-laboratory of each study period
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean and nadir oxygen saturation
Prazo: At day 30 during the overnight in-laboratory of each study period
|
Mean and nadir oxygen saturation measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
|
At day 30 during the overnight in-laboratory of each study period
|
|
Sleep efficiency
Prazo: At day 30 during the overnight in-laboratory of each study period
|
Sleep efficiency measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
|
At day 30 during the overnight in-laboratory of each study period
|
|
Wake after sleep onset (WASO)
Prazo: At day 30 during the overnight in-laboratory of each study period
|
Wake after sleep onset (WASO) measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
|
At day 30 during the overnight in-laboratory of each study period
|
|
Sleep latency
Prazo: At day 30 during the overnight in-laboratory of each study period
|
Sleep latency measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
|
At day 30 during the overnight in-laboratory of each study period
|
|
REM latency
Prazo: At day 30 during the overnight in-laboratory of each study period
|
REM latency measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
|
At day 30 during the overnight in-laboratory of each study period
|
|
Percentage of time spent in NREM stage 1-3 and REM stage
Prazo: At day 30 during the overnight in-laboratory of each study period
|
Percentage of time spent in NREM stage 1-3 and REM stage measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores in NREM stage 3 and REM mean better outcome but higher scores in NREM stage 1 and 2 mean worse outcome)
|
At day 30 during the overnight in-laboratory of each study period
|
|
Arousal index
Prazo: At day 30 during the overnight in-laboratory of each study period
|
Arousal index measured by polysomnography (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome)
|
At day 30 during the overnight in-laboratory of each study period
|
|
OSLER error index
Prazo: On the morning of the in-laboratory polysomnography
|
Oxford Sleep Resistance Test (OSLER) test (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome)
|
On the morning of the in-laboratory polysomnography
|
|
Epworth Sleepiness Scale (ESS)
Prazo: Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
|
Epworth Sleepiness Scale (ESS) questionnaires (scale: point: minimum 0 point - maximum 24 point; higher scores mean worse outcome)
|
Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
|
|
Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T)
Prazo: Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
|
Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T) (scale: point: minimum 5 point - maximum 20 point; higher scores mean better outcome)
|
Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
|
|
Pittsburgh Sleep Quality Index
Prazo: Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
|
Pittsburgh Sleep Quality Index (scale: point: minimum 0 point - maximum 21 point; higher scores mean worse outcome)
|
Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
|
|
Total sleep time
Prazo: During day 1-29 of intervention
|
Total sleep time measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean better outcome)
|
During day 1-29 of intervention
|
|
Sleep efficiency
Prazo: During day 1-29 of intervention
|
Sleep efficiency measured by actigraphy (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
|
During day 1-29 of intervention
|
|
Wake after sleep onset (WASO)
Prazo: During day 1-29 of intervention
|
Wake after sleep onset (WASO) measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
|
During day 1-29 of intervention
|
|
Sleep latency
Prazo: During day 1-29 of intervention
|
Sleep latency measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
|
During day 1-29 of intervention
|
|
Total sleep time
Prazo: During day 1-29 of intervention
|
Total sleep time recorded by sleep diary (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean better outcome)
|
During day 1-29 of intervention
|
|
Sleep efficiency
Prazo: During day 1-29 of intervention
|
Sleep efficiency recorded by sleep diary (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
|
During day 1-29 of intervention
|
|
Wake after sleep onset (WASO)
Prazo: During day 1-29 of intervention
|
Wake after sleep onset (WASO) recorded by sleep diary (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
|
During day 1-29 of intervention
|
|
Sleep latency
Prazo: During day 1-29 of intervention
|
Sleep latency recorded by sleep diary (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
|
During day 1-29 of intervention
|
|
Sleep quality
Prazo: During day 1-29 of intervention
|
Sleep quality recorded by sleep diary (5-point Likert scale of 1-5; higher score mean better outcome)
|
During day 1-29 of intervention
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Sarocha Vivatvakin, MD, Department of Medicine, Faculty of Medicine
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
30 de junho de 2028
Conclusão do estudo (Estimado)
30 de junho de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
26 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de julho de 2026
Primeira postagem (Real)
6 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de julho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Nervoso
- Doenças Respiratórias
- Distúrbios Respiratórios
- Distúrbios do Sono Vigília
- Sinais e Sintomas Respiratórios
- Distúrbios do Sono Intrínsecos
- Dissônias
- Síndromes da Apneia do Sono
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Apnéia do Sono, Obstrutiva
- Apnéia
- Lemborexant
Outros números de identificação do estudo
- 0594/69
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Sim
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