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Completed

NCT Number: NCT05197855

Sleep Quality Evolution: Dreem Under CPAP

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.

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Key information

Conditions

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

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble Alpes University Hospital

Grenoble, France

About this study

This study aims to evaluate the quality of sleep, principally the deep slow-wave sleep (sleep stage N3) before and after the initiation of continuous positive airway pressure (CPAP) treatment.

70 newly diagnosed patients with OSA requiring CPAP treatment, will be included.

For the study, they will wear the Dreem 3 headband and pulse oximeter at home before initiation of CPAP (for 7 nights) and during the first month of CPAP (for a minimum of 9 nights). They will be also equipped with a glucose sensor and a pedometer during the entire study period before and after CPAP treatment.

Patients will also complete questionnaires about their health status before CPAP treatment (at inclusion) and after one month of treatment

These devices will allow the measurements of different parameters: sleep stages, total sleep time, sleep measures derived from sleep stages, snoring, breathing rate, heart rate head movements, arterial hemoglobin oxygen saturation, pulse rate, continuous subcutaneous glucose level, and physical activity data (average daily steps, average distance walked per day).

This will generate interesting data on the sleep parameters and their evolution during the initiation of the CPAP treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

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

    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

Secondary outcomes

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

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

    Sleep stages (W, N1, N2 and REM) and total sleep time spent in each sleep stage, recorded by the Dreem 3. All the data units are in minutes

  2. Duration of different sleep times

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

    Sleep parameters recorded by Dreem 3 headband: sleep times (bedtime, total sleep time (TST), sleep onset delay (SOD),time in bed (TIB), time awake after falling asleep (WASO), final wakefulness time)

  3. The percentage of time while sleeping

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

    Sleep parameter recorded by Dreem 3 headband: sleep efficiency ((TST/TIB) x100)

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

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

    sleep spindle density expressed in Hertz recorded by the EEG sensors

  5. The frequence of snoring while sleeping recorded by Dreem 3 headband

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

    snoring is expressed in decibel minute recorded by a microphone integrated in the Dreem3

  6. Respiratory rate measurment recorded by Dreem 3 headband

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

    It is expressed in breathe per minute recorded accelerometer sensor

  7. Heart rate measurement while sleepingrecorded by Dreem 3 headband

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

    Expressed in beats per minute recorded by accelerometer sensor

  8. The position of the head changes while sleeping recorded by Dreem 3 headband

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

    Head movements are recorded by an accelerometer sensor in the Dreem 3 Headband

  9. Evolution of the nocturnal oximetry

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

    Nocturnal oxygen saturation measured by a pulse oximeter

  10. Evolution of the subcutaneous glucose level

    Time frame: 7 nights before CPAP initiation and for a month after CPAP initiation

    Continuous subcutaneous glucose level (measured by FreeStyle Libre 2 continuous glucose sensor)

  11. Evolution of glycemia

    Time frame: At inclusion and a month after CPAP initiation

    Blood glucose level by blood sampling

  12. Average daily number of steps

    Time frame: 7 nights before CPAP initiation and for a month after CPAP initiation

    It will be measured by a Garmin Vivofit 3 pedometer expressed in steps/day

  13. Average distance walked per day

    Time frame: 7 nights before CPAP initiation and for a month after CPAP initiation

    It will be measured by a Garmin Vivofit 3 pedometer expressed in Kilometer

  14. Sleep quality assessed by Pittsburg questionnaire

    Time frame: At inclusion and a month after CPAP initiation

    The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.

  15. Severity of insomnia measured by the index sverety of insomnia questionnaire

    Time frame: At inclusion and a month after CPAP initiation

    The general ISI score varies between 0 and 28: -7 = No insomnia 8-14 = Sub-clinical insomnia (mild) 15-21 = Clinical insomnia (moderate) 22-28 = Clinical insomnia (severe)

  16. Evolution of the somnolence

    Time frame: At inclusion and a month after CPAP initiation

    Epworth Sleepiness Score (ESS):

    0 = no chance of dozing or falling asleep

    • = low chance of falling asleep
    • = medium chance of falling asleep
    • = high chance of falling asleep

  17. Evolution of the quality of life by the Short Form 36 health survey questionnaire

    Time frame: At inclusion and a month after CPAP initiation

    A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  18. Evolution of the compliance of CPAP treatment

    Time frame: For a month during CPAP treatment

    Collection of average CPAP treatment use (in hours/day) provided by telemonitoring

  19. Evolution of the effectiveness of CPAP treatment

    Time frame: For a month during CPAP treatment

    Collection of residual AHI provided by telemonitoring

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • AGIR à Dom
  • Dreem

Registry information

Official study title

Evolution of Sleep Quality During the Initiation of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome: An Exploratory Study

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2022
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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