Evaluating sleep quality changes with CPAP treatment using Dreem technology
Evolution of Sleep Quality During the Initiation of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome: an Exploratory Study
NA · University Hospital, Grenoble · NCT05197855
This study is testing how using a CPAP machine affects the sleep quality of people newly diagnosed with obstructive sleep apnea by tracking their sleep patterns at home with a special headband.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Grenoble (other) |
| Locations | 1 site (Grenoble) |
| Trial ID | NCT05197855 on ClinicalTrials.gov |
What this trial studies
This study evaluates the quality of sleep, particularly deep slow-wave sleep, in patients newly diagnosed with obstructive sleep apnea (OSA) before and after starting continuous positive airway pressure (CPAP) treatment. Participants will wear a Dreem 3 headband and pulse oximeter at home for several nights before and during the first month of CPAP therapy. The study will collect data on various sleep parameters, including sleep stages, total sleep time, and other health metrics, to understand the effects of CPAP on sleep quality over time. Questionnaires will also be administered to assess health status changes related to treatment.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed patients with obstructive sleep apnea who require CPAP treatment and can use a mobile application.
Not a fit: Patients already treated for obstructive sleep apnea or those with severe chronic lung disease or unstable cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of sleep apnea and enhanced sleep quality for patients using CPAP.
How similar studies have performed: Other studies have shown promise in using home-based monitoring technologies for sleep assessment, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients newly diagnosed with OSA requiring CPAP treatment * Patients able to use a mobile application on a smartphone or tablet * Patients with access to a wi-fi internet connection at home * Patients agreeing to remote monitoring of CPAP compliance data by the home care provider * Patients who have signed consent to participate in the study * Subjects affiliated to a social security Exclusion Criteria: * Patients already treated for OSA * Patients treated with a sleep aid (sleeping medications) * Patients with severe chronic obstructive or restrictive lung disease with or without oxygen * Patients with unstable cardiovascular disease or severe heart failure requiring hospitalization within the last three months or meeting New York Heart Association criteria, Class III or IV disease * Subjects listed in articles L1121-5 to L1121-8: pregnant women, feeding and parturients, subjects deprived of liberty by judicial or administrative decision, persons under legal protection * Persons in a period of exclusion from another study or ongoing participation in a drug study * Subjects likely, at the investigator's discretion, to be uncooperative or noncompliant with the obligations inherent to participation in the study
Where this trial is running
Grenoble
- Grenoble Alpes University Hospital — Grenoble, France (RECRUITING)
Study contacts
- Principal investigator: Jean Louis Pépin, MD, PhD — Grenoble Alpes University Hospital (CHUGA)
- Study coordinator: Jean Louis Pépin, MD, PhD
- Email: JPepin@chu-grenoble.fr
- Phone: 0033 476 768 766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Apnea, Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Technological innovations, Sleep Stages, Dreem Headband