Sleep Quality Evolution: Dreem Under CPAP

NCT05197855 | Recruiting

• 1 other identifier: 38RC21.0346
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Sleep Apnea; Obstructive Sleep Apnea

Keywords

Continuous Positive Airway Pressure (CPAP); Technological innovations; Sleep Stages; Dreem Headband

Outcome Measures

Primary Outcomes (1)

• Duration of deep slow-wave sleep (sleep stage N3) before and after initiation of continuous positive airway pressure (CPAP) treatment.

  Time spent on the deep slow-wave sleep stage (stage N3 sleep), recorded by the Dreem 3 headband, from 7 nights before and 9 nights after initiation of CPAP treatment

  7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation

Secondary Outcomes (19)

• Duration of the other sleep stages (W, N1, N2 and REM)

  7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation

• Duration of different sleep times

  7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation

• The percentage of time while sleeping

  7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation

• The frequences of sleep waves during the NREM sleep stage recorded by Dreem 3 headband

  7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation

• The frequence of snoring while sleeping recorded by Dreem 3 headband

  7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation

Study Arms (1)

Technological innovations and CPAP

EXPERIMENTAL

Patients will be equipped with 4 devices: a Dreem 3 Headband, a pulse oximeter, a continuous glucose sensor, and a pedometer. In parallel they will be equipped by the CPAP at home by Icadom.

Device: Deem 3 Headband

Interventions

Deem 3 Headband DEVICE

The patient will wear the Dreem 3 headband and pulse oximeter at home before initiation of CPAP (for 7 nights) and during a month of treatment (for a minimum of 9 nights), after the initiation of CPAP. He will also wear a glucose sensor and a pedometer during the entire study period before and after CPAP treatment.

Technological innovations and CPAP

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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
• Subjects likely, at the investigator's discretion, to be uncooperative or noncompliant with the obligations inherent to participation in the study

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Dreem: collaborator
• AGIR à Dom: collaborator

Study Sites (1)

Grenoble Alpes University Hospital

Grenoble, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jean Louis Pépin, MD, PhD

  Grenoble Alpes University Hospital (CHUGA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Louis Pépin, MD, PhD

CONTACT

0033 476 768 766; JPepin@chu-grenoble.fr

Marie Joyeux-Faure, PharmD, PhD

CONTACT

MJoyeuxfaure@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 20, 2022
• Study Start: October 3, 2022
• Primary Completion: November 3, 2025
• Study Completion: December 3, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)