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Sleep Quality Evolution: Dreem Under CPAP

NCT05197855 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-12-27

No results posted yet for this study

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

Interventions

DEVICE

Deem 3 Headband

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.

Sponsors & Collaborators

  • Dreem

    collaborator INDUSTRY

  • AGIR à Dom

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Jean Louis Pépin, MD, PhD · Grenoble Alpes University Hospital (CHUGA)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2025-11-03
Completion
2025-12-03

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05197855 on ClinicalTrials.gov