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- Ensaio Clínico NCT07714330
Effectiveness of Audio Cues to Achieve Positional Therapy in Patients With Positional Obstructive Sleep Apnea
Effectiveness of WhisperPT's Audio Cues to Achieve Positional Therapy in Patients With Positional Obstructive Sleep Apnea
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Michael Swertfager
- Número de telefone: 408-499-6884
- E-mail: mswertfager@sleepdev.com
Estude backup de contato
- Nome: Joshua Roland, M.D.
- E-mail: jrolandsleep@gmail.com
Locais de estudo
-
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California
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Burlingame, California, Estados Unidos, 94010
- Recrutamento
- Peninsula Sleep Center
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Contato:
- Mehran Farid, M.D.
- Número de telefone: 650-779 4055
- E-mail: mehran@peninsulasleep.com
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Investigador principal:
- Mehran Farid, M.D.
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Diagnosing sleep study identified a significant positional component to their obstructive sleep apnea (OSA) diagnosis as measured by at least a 50% reduction in Apnea-Hypopnea Index (AHI) while sleeping non-supine compared to supine
- Diagnosing sleep study included at least 40% of the night recorded in supine and at least 20% of the night in non-supine position
- Have an overall AHI > 10 (4% desaturation)
- Diagnosing sleep study included a minimum of 5 hours total sleep time (TST)
- Willing to abstain from use of any other treatments for sleep-disordered breathing beginning at least 3 days prior to at-home study testing and for the remaining duration of their study participation
- Between ages 18-75
- Must be able to refrain from alcohol use during nights of at-home study testing
- Speaks and reads English sufficiently to understand the study informed consent, study instructions, and study materials
- Signs study-specific informed consent form
Exclusion Criteria:
-Active medical conditions that would prevent study participation as determined by the principal investigator, including: Inability to easily move from between back and side in both directions Inability to sleep in lateral or supine position due to injury or a medical condition OR inability to sleep in a non-elevated/ tilted bed
- Requiring medications to sleep
- Prior diagnosis of a significant other sleep disorder such as restless leg syndrome/periodic limb movement disorder, primary central sleep apnea, pronounced insomnia, parasomnias, central disorder of hypersomnolence, etc
- An active ear infection OR an ear infection within the past month OR a history of >3 ear infections per year
- Unusual outer ear, including enlarged or extra small anatomy, that prevents device use
- Significant hearing impairment or ear skin issues, including:
Participants with cochlear implants or those who will be affected by small magnets in the ear
- Suffering from tinnitus
- BMI >35
- Current use of any illegal drugs.
- Currently pregnant or currently lactating
- Current enrollment in a clinical study of any other unapproved investigational drug or device.
- Inability or unwillingness to comply with the study requirements.
- Any other condition or laboratory value that could, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the participant.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Investigational Positional Therapy Device
After completing a WatchPAT home sleep study, participants use WhisperPT's positional therapy device for a 3-day acclimation period, followed by a repeat WatchPAT home sleep study with positional therapy in place.
|
The investigational intervention is a non-invasive, investigational in-ear positional therapy device worn in the ear during sleep.
The device continuously monitors head position and delivers gentle audio cues when the participant remains in the supine (back-sleeping) position to encourage a return to a non-supine sleeping position.
The device is evaluated as part of a structured protocol including baseline assessment, acclimation, and treatment nights.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Participants Achieving ≥50% Reduction in AHI
Prazo: Intervention assessment (Night 5), within approximately 7 days
|
Proportion of participants achieving a minimum 50% reduction in apnea-hypopnea index (AHI) during treatment compared with baseline, untreated AHI as measured by the WatchPAT ONE home sleep test.
|
Intervention assessment (Night 5), within approximately 7 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of participants with supine sleep percentage of less than 15%
Prazo: Intervention assessment (Night 5), within approximately 7 days
|
Proportion of participants with less than 15% of total sleep time spent in the supine position during the intervention assessment, as measured by the WatchPAT ONE home sleep test.
|
Intervention assessment (Night 5), within approximately 7 days
|
|
Self-reported Comfort, Overnight Retention, and Ease of Device Use
Prazo: Study completion (approximately 7 days)
|
Participant-reported comfort while wearing the investigational device, overnight device retention, and ease of device use, assessed using the study exit questionnaire.
|
Study completion (approximately 7 days)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Michael Swertfager, SleepDev, Inc
- Diretor de estudo: Joshua Roland, M.D., SleepDev, Inc
- Investigador principal: Mehran Farid, M.D.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CIP-001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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