Actively Recruiting

Phase Not Applicable
Age: 30Years - 65Years
All Genders
ID05197855

Evolution of Sleep Quality During the Start of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome Using Dreem 3 Headband Monitoring

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

Researchers are investigating how continuous positive airway pressure (CPAP) treatment affects sleep quality, focusing on deep slow-wave sleep (sleep stage N3) in people newly diagnosed with obstructive sleep apnea (OSA). The study examines sleep improvements in real-life conditions over several nights at home, using advanced technology to gather detailed sleep data. This research aims to understand how sleep parameters change during the first weeks of CPAP treatment and whether these changes relate to improvements in sleepiness, quality of life, and treatment adherence. Participants will wear the Dreem 3 headband and a pulse oximeter at home for seven nights before starting CPAP treatment and for at least nine nights during the first month of treatment. They will also wear a glucose sensor and pedometer throughout the study period, before and after beginning CPAP. These devices will track sleep stages, total sleep time, snoring, breathing rate, heart rate, oxygen saturation, glucose levels, and physical activity, allowing a comprehensive assessment of sleep and health changes. During the study, participants will complete health questionnaires before starting CPAP and after one month of treatment. Researchers will measure the duration of deep slow-wave sleep over multiple nights before and after CPAP initiation. This study will provide valuable data on sleep quality evolution, treatment compliance, and health outcomes. The total study period includes one week of baseline measurement and one month of treatment monitoring at home.

CONDITIONS

Official Title

Sleep Quality Evolution: Dreem Under CPAP

Who Can Participate

Age: 30Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Grenoble Alpes University Hospital

Grenoble, France

Actively Recruiting

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Research Team

J

Jean Louis Pépin, MD, PhD

M

Marie Joyeux-Faure, PharmD, PhD

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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