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Sleep Quality Evolution: Dreem Under CPAP

Primary Purpose

Sleep Apnea, Obstructive Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Deem 3 Headband
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea focused on measuring Continuous Positive Airway Pressure (CPAP), Technological innovations, Sleep Stages, Dreem Headband

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grenoble Alpes University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Technological innovations and CPAP

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of the other sleep stages (W, N1, N2 and REM)
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
Duration of different sleep times
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)
The percentage of time while sleeping
Sleep parameter recorded by Dreem 3 headband: sleep efficiency ((TST/TIB) x100)
The frequences of sleep waves during the NREM sleep stage recorded by Dreem 3 headband
sleep spindle density expressed in Hertz recorded by the EEG sensors
The frequence of snoring while sleeping recorded by Dreem 3 headband
snoring is expressed in decibel minute recorded by a microphone integrated in the Dreem3
Respiratory rate measurment recorded by Dreem 3 headband
It is expressed in breathe per minute recorded accelerometer sensor
Heart rate measurement while sleepingrecorded by Dreem 3 headband
Expressed in beats per minute recorded by accelerometer sensor
The position of the head changes while sleeping recorded by Dreem 3 headband
Head movements are recorded by an accelerometer sensor in the Dreem 3 Headband
Evolution of the nocturnal oximetry
Nocturnal oxygen saturation measured by a pulse oximeter
Evolution of the subcutaneous glucose level
Continuous subcutaneous glucose level (measured by FreeStyle Libre 2 continuous glucose sensor)
Evolution of glycemia
Blood glucose level by blood sampling
Average daily number of steps
It will be measured by a Garmin Vivofit 3 pedometer expressed in steps/day
Average distance walked per day
It will be measured by a Garmin Vivofit 3 pedometer expressed in Kilometer
Sleep quality assessed by Pittsburg questionnaire
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.
Severity of insomnia measured by the index sverety of insomnia questionnaire
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)
Evolution of the somnolence
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
Evolution of the quality of life by the Short Form 36 health survey questionnaire
A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Evolution of the compliance of CPAP treatment
Collection of average CPAP treatment use (in hours/day) provided by telemonitoring
Evolution of the effectiveness of CPAP treatment
Collection of residual AHI provided by telemonitoring

Full Information

First Posted
December 1, 2021
Last Updated
October 4, 2022
Sponsor
University Hospital, Grenoble
Collaborators
Dreem, AGIR à Dom
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1. Study Identification

Unique Protocol Identification Number
NCT05197855
Brief Title
Sleep Quality Evolution: Dreem Under CPAP
Official Title
Evolution of Sleep Quality During the Initiation of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome: An Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
November 3, 2024 (Anticipated)
Study Completion Date
February 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Dreem, AGIR à Dom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive Sleep Apnea
Keywords
Continuous Positive Airway Pressure (CPAP), Technological innovations, Sleep Stages, Dreem Headband

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Technological innovations and CPAP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Deem 3 Headband
Intervention Description
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 Outcome Measure Information:
Title
Duration of deep slow-wave sleep (sleep stage N3) before and after initiation of continuous positive airway pressure (CPAP) treatment.
Description
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
Time Frame
7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Secondary Outcome Measure Information:
Title
Duration of the other sleep stages (W, N1, N2 and REM)
Description
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
Time Frame
7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Title
Duration of different sleep times
Description
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)
Time Frame
7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Title
The percentage of time while sleeping
Description
Sleep parameter recorded by Dreem 3 headband: sleep efficiency ((TST/TIB) x100)
Time Frame
7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Title
The frequences of sleep waves during the NREM sleep stage recorded by Dreem 3 headband
Description
sleep spindle density expressed in Hertz recorded by the EEG sensors
Time Frame
7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Title
The frequence of snoring while sleeping recorded by Dreem 3 headband
Description
snoring is expressed in decibel minute recorded by a microphone integrated in the Dreem3
Time Frame
7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Title
Respiratory rate measurment recorded by Dreem 3 headband
Description
It is expressed in breathe per minute recorded accelerometer sensor
Time Frame
7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Title
Heart rate measurement while sleepingrecorded by Dreem 3 headband
Description
Expressed in beats per minute recorded by accelerometer sensor
Time Frame
7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Title
The position of the head changes while sleeping recorded by Dreem 3 headband
Description
Head movements are recorded by an accelerometer sensor in the Dreem 3 Headband
Time Frame
7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Title
Evolution of the nocturnal oximetry
Description
Nocturnal oxygen saturation measured by a pulse oximeter
Time Frame
7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Title
Evolution of the subcutaneous glucose level
Description
Continuous subcutaneous glucose level (measured by FreeStyle Libre 2 continuous glucose sensor)
Time Frame
7 nights before CPAP initiation and for a month after CPAP initiation
Title
Evolution of glycemia
Description
Blood glucose level by blood sampling
Time Frame
At inclusion and a month after CPAP initiation
Title
Average daily number of steps
Description
It will be measured by a Garmin Vivofit 3 pedometer expressed in steps/day
Time Frame
7 nights before CPAP initiation and for a month after CPAP initiation
Title
Average distance walked per day
Description
It will be measured by a Garmin Vivofit 3 pedometer expressed in Kilometer
Time Frame
7 nights before CPAP initiation and for a month after CPAP initiation
Title
Sleep quality assessed by Pittsburg questionnaire
Description
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.
Time Frame
At inclusion and a month after CPAP initiation
Title
Severity of insomnia measured by the index sverety of insomnia questionnaire
Description
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)
Time Frame
At inclusion and a month after CPAP initiation
Title
Evolution of the somnolence
Description
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
Time Frame
At inclusion and a month after CPAP initiation
Title
Evolution of the quality of life by the Short Form 36 health survey questionnaire
Description
A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
At inclusion and a month after CPAP initiation
Title
Evolution of the compliance of CPAP treatment
Description
Collection of average CPAP treatment use (in hours/day) provided by telemonitoring
Time Frame
For a month during CPAP treatment
Title
Evolution of the effectiveness of CPAP treatment
Description
Collection of residual AHI provided by telemonitoring
Time Frame
For a month during CPAP treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Louis Pépin, MD, PhD
Phone
0033 476 768 766
Email
JPepin@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Joyeux-Faure, PharmD, PhD
Email
MJoyeuxfaure@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Louis Pépin, MD, PhD
Organizational Affiliation
Grenoble Alpes University Hospital (CHUGA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grenoble Alpes University Hospital
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Louis Pépin, MD, PhD
Phone
0033 476 768 766
Email
JPepin@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Marie Joyeux-Faure, PharmD, PhD
Email
MJoyeuxfaure@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Jean Louis Pépin, MD, PhD
First Name & Middle Initial & Last Name & Degree
Renaud Tamisier, MD,PhD
First Name & Middle Initial & Last Name & Degree
Rita CHERPEC épouse CLIN, MD,PhD
First Name & Middle Initial & Last Name & Degree
Marie DESTORS, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Sleep Quality Evolution: Dreem Under CPAP

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