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?"
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Sarah E Warner, BS
- Numero di telefono: 412-623-2706
- Email: warners3@upmc.edu
Luoghi di studio
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- The Center for Sleep and Cardiovascular Outcomes Research (C-SCOR) Sleep Laboratory
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Contatto:
- Ata M Kaynar, MD, MPH
- Numero di telefono: 412-692-2784
- Email: kaynarm@upmc.edu
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Contatto:
- Sarah E Warner, BS
- Email: warners3@upmc.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Apnea-Hypopnea Index (AHI)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ata M Kaynar, MD, MPH, University of Pittsburgh
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY25080031
Piano per i dati dei singoli partecipanti (IPD)
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