- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Michael Swertfager
- Numéro de téléphone: 408-499-6884
- E-mail: mswertfager@sleepdev.com
Sauvegarde des contacts de l'étude
- Nom: Joshua Roland, M.D.
- E-mail: jrolandsleep@gmail.com
Lieux d'étude
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California
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Burlingame, California, États-Unis, 94010
- Recrutement
- Peninsula Sleep Center
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Contact:
- Mehran Farid, M.D.
- Numéro de téléphone: 650-779 4055
- E-mail: mehran@peninsulasleep.com
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Chercheur principal:
- Mehran Farid, M.D.
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Participants Achieving ≥50% Reduction in AHI
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of participants with supine sleep percentage of less than 15%
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Michael Swertfager, SleepDev, Inc
- Directeur d'études: Joshua Roland, M.D., SleepDev, Inc
- Chercheur principal: Mehran Farid, M.D.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CIP-001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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