- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Michael Swertfager
- Telefonnummer: 408-499-6884
- E-post: mswertfager@sleepdev.com
Studera Kontakt Backup
- Namn: Joshua Roland, M.D.
- E-post: jrolandsleep@gmail.com
Studieorter
-
-
California
-
Burlingame, California, Förenta staterna, 94010
- Rekrytering
- Peninsula Sleep Center
-
Kontakt:
- Mehran Farid, M.D.
- Telefonnummer: 650-779 4055
- E-post: mehran@peninsulasleep.com
-
Huvudutredare:
- Mehran Farid, M.D.
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Participants Achieving ≥50% Reduction in AHI
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of participants with supine sleep percentage of less than 15%
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Michael Swertfager, SleepDev, Inc
- Studierektor: Joshua Roland, M.D., SleepDev, Inc
- Huvudutredare: Mehran Farid, M.D.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CIP-001
Plan för individuella deltagardata (IPD)
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