Actively Recruiting
Sleep Quality Evolution: Dreem Under CPAP
Led by University Hospital, Grenoble · Updated on 2024-12-27
70
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Grenoble
Lead Sponsor
D
Dreem
Collaborating Sponsor
AI-Summary
What this Trial Is About
Continuous positive airway pressure (CPAP) has a caricatural effect in reducing nocturnal respiratory abnormalities and improving the micro-and macrostructure of sleep. Studies characterizing the improvement of acute sleep parameters after the initiation of CPAP are limited to one or two nights of polysomnographic recording. This is related to the cost of performing these studies with repeated recordings in the laboratory and to the acceptability by patients to perform multiple nights of recordings. Investigators currently have powerful and reliable methods allowing us to carry out nights at home in the patient's ecosystem, in real-life conditions. The characterization of sleep parameters by these methods is equivalent to a polysomnographic recording. These technological innovations will allow us to characterize sleep before the initiation of CPAP treatment during several nights performed at home. Investigators will then be able to characterize the kinetics and stability of the improvement of sleep parameters in patients with obstructive sleep apnea syndrome in whom continuous positive airway pressure is initiated. These data will be original and will serve as exploratory data to judge whether the objective improvement of sleep parameters in the first weeks of treatment is associated with improvement in sleepiness, quality of life, and compliance with treatment.
CONDITIONS
Official Title
Sleep Quality Evolution: Dreem Under CPAP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
- Pregnant, feeding, or parturient women
- 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 to be uncooperative or noncompliant with study obligations at the investigator's discretion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Grenoble Alpes University Hospital
Grenoble, France
Actively Recruiting
Research Team
J
Jean Louis Pépin, MD, PhD
CONTACT
M
Marie Joyeux-Faure, PharmD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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