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?"
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Sarah E Warner, BS
- Telefonnummer: 412-623-2706
- E-post: warners3@upmc.edu
Studiesteder
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15213
- The Center for Sleep and Cardiovascular Outcomes Research (C-SCOR) Sleep Laboratory
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Ta kontakt med:
- Ata M Kaynar, MD, MPH
- Telefonnummer: 412-692-2784
- E-post: kaynarm@upmc.edu
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Ta kontakt med:
- Sarah E Warner, BS
- E-post: warners3@upmc.edu
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: C-Lift
Participants will wear the C-Lift during sleep for one night in a sleep lab.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Apnea-Hypopnea Index (AHI)
Tidsramme: The device will be worn for the duration of the sleep-study, approximately 8 hours.
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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.
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Participant's Description of Outcomes
Tidsramme: 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.
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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
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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.
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ata M Kaynar, MD, MPH, University of Pittsburgh
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY25080031
Plan for individuelle deltakerdata (IPD)
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