- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Michael Swertfager
- Número de teléfono: 408-499-6884
- Correo electrónico: mswertfager@sleepdev.com
Copia de seguridad de contactos de estudio
- Nombre: Joshua Roland, M.D.
- Correo electrónico: jrolandsleep@gmail.com
Ubicaciones de estudio
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California
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Burlingame, California, Estados Unidos, 94010
- Reclutamiento
- Peninsula Sleep Center
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Contacto:
- Mehran Farid, M.D.
- Número de teléfono: 650-779 4055
- Correo electrónico: mehran@peninsulasleep.com
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Investigador principal:
- Mehran Farid, M.D.
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participants Achieving ≥50% Reduction in AHI
Periodo de tiempo: Intervention assessment (Night 5), within approximately 7 days
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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.
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Intervention assessment (Night 5), within approximately 7 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of participants with supine sleep percentage of less than 15%
Periodo de tiempo: Intervention assessment (Night 5), within approximately 7 days
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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.
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Intervention assessment (Night 5), within approximately 7 days
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Self-reported Comfort, Overnight Retention, and Ease of Device Use
Periodo de tiempo: Study completion (approximately 7 days)
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Participant-reported comfort while wearing the investigational device, overnight device retention, and ease of device use, assessed using the study exit questionnaire.
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Study completion (approximately 7 days)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Michael Swertfager, SleepDev, Inc
- Director de estudio: Joshua Roland, M.D., SleepDev, Inc
- Investigador principal: Mehran Farid, M.D.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CIP-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .