C-LIFT Efficacy in Patients With Obstructive Sleep Apnea (EOSA)
Efficacy Testing of Active Head Tilt Chin-Lift Positioning (C-LIFT) Device in Patients With Obstructive Sleep Apnea
The goal of this clinical trial is to evaluate the efficacy of the C-Lift Device as a non-invasive treatment for Sleep Disordered Breathing (SDB) within the population of adults diagnosed with moderate to severe Obstructive Sleep Apnea (OSA), who are not currently being treated with a Continuous Positive Airway Pressure (CPAP) device or other intervention.
This study aims to answer 2 main questions: "Will C-Lift demonstrate a qualitative improvement in a participant's perception/description of their sleep-quality?" And, "Will wearing the C-Lift Device overnight show a quantitative improvement in a participant's oxygen saturation?"
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Sarah E Warner, BS
- Telefonnummer: 412-623-2706
- E-post: warners3@upmc.edu
Studieorter
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Förenta staterna, 15213
- The Center for Sleep and Cardiovascular Outcomes Research (C-SCOR) Sleep Laboratory
-
Kontakt:
- Ata M Kaynar, MD, MPH
- Telefonnummer: 412-692-2784
- E-post: kaynarm@upmc.edu
-
Kontakt:
- Sarah E Warner, BS
- E-post: warners3@upmc.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Diagnosis of moderate to severe OSA (≥16 AHI events per hour)
- Previously failed/refused CPAP
- Not currently/actively participating in treatment for OSA
Exclusion Criteria:
- Diagnosis of mild OSA (AHI<15 events per hour)
- Received treatment for OSA in the 2-weeks prior to the sleep-study EX: CPAP, other oral device
- Received prior surgical treatment for OSA EX: hypoglossal nerve stimulation (NOT including Tonsillectomy)
- Diagnosis of comorbid sleep disorder EX: Insomnia
- History of other sleep-disordered breathing EX: central sleep apnea, hypoventilation syndrome
- History of cervical spine injury/surgery
- Currently receiving oxygen therapy
- Baseline oxygen saturation <90%
- Currently pregnant
- History of substance abuse
- Neck circumference >20 inches
- Regular use of medications which can impact sleep-disordered breathing or related symptoms.
EX: opioids, benzodiazepines, gabapentin, antipsychotics, amphetamines or other stimulants.
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: C-Lift
Participants will wear the C-Lift during sleep for one night in a sleep lab.
|
The Head-Tilt, Chin-Lift Positioning Device (C-Lift) is embedded with a variety of sensors to detect SDB events and OSA symptoms.
Audible snoring, sounds of gasping, or decreased oxygen saturation will trigger the cushioned lining the neck brace, to inflate/deflate, as needed, to open the airway and maintain stable breathing.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Apnea-Hypopnea Index (AHI)
Tidsram: The device will be worn for the duration of the sleep-study, approximately 8 hours.
|
The Apnea-Hypopnea Index (AHI) represents the number of SDB Events, like pauses in breathing (apnea) or airway obstructions (hypopnea), per hour of sleep. The AHI Score indicates the severity of the OSA symptoms, ranging from mild (AHI: <15 events per hour), to moderate (15-30 events per hour), to severe (>30 events per hour). A lower AHI score indicates fewer SDB events and a better quality of sleep. A higher an AHI score, means more frequent breathing interruptions, lower quality sleep and severe symptoms of OSA. Investigators will compare AHI after wearing the device and the participant's AHI prior to wearing the device. |
The device will be worn for the duration of the sleep-study, approximately 8 hours.
|
|
Participant's Description of Outcomes
Tidsram: This outcome measure will be obtained from subject feedback provided after the subject has worn the device for the duration of the sleep-study, which will last approximately 8 hours.
|
Qualitative description of outcomes on efficacy, and comfort.
(i.e.
improved symptoms of sleep apnea) Standford Sleepiness Scale, Richards-Campbell Sleep Questionnaire, and "PROMIS- Sleep Disturbance Short Form-8a" (also referred to as the "DSM-5-TR Level 2- Sleep Disturbance- Adult Measure") will be used pre- and post-intervention to establish the participant's perception of their sleep-quality during the overnight study compared to their baseline.
A custom "C-Lift Efficacy Questionnaire" will be given post-intervention to document the participant's experience with the device and assess their ability to tolerate
|
This outcome measure will be obtained from subject feedback provided after the subject has worn the device for the duration of the sleep-study, which will last approximately 8 hours.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ata M Kaynar, MD, MPH, University of Pittsburgh
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
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
- STUDY25080031
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .