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Performance Evaluation of the Dreem 3 System for Sleep Assessment in Patients With Insomnia

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Dreem 3 System vs PSG
Sponsored by
Dreem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Insomnia focused on measuring Dreem, Insomnia symptoms, Sleep, Polysomnography, Performance, EEG, Sleep monitoring

Eligibility Criteria

22 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects must be ≥ 22 and ≤ 70 years old inclusive.
  • Able to read, understand and sign an informed consent form.
  • Subjects with stable disease or/and taking stable medications for at least 2 months can be included under Principal Investigator or Sub-Investigator discretion
  • Self-reported insomnia symptoms (by means of a questionnaire completed by the participant before their visit to the sleep lab) as defined by International Classification of Sleep Disorders, third edition (ICSD-3), confirmed by a clinician.

Exclusion Criteria:

  • Female subjects who are pregnant, or breastfeeding.
  • Subject under 22 and above 70 years old inclusive.
  • Not able to read, understand and sign an informed consent form
  • Subjects with BMI ≥ 40

  • Taking medications that induce somnolence or wakefulness, or that can interfere with sleep recording:

    • If the subject is taking OTC medications that can induce somnolence or wakefulness, he/she must not take it the day of the measurement.
    • Prescription only drugs that induce somnolence or wakefulness must be stopped one week before, as PI or Sub-I discretion and/or review with subject's physician.
  • Subjects previously diagnosed with Obstructive Sleep Apnea (OSA), REM Sleep Disorder, Narcolepsy, Hypersomnia, or significant difficulty breathing due to underlying condition(s), or subjects diagnosed with Central Nervous System (CNS) disease.
  • Subjects that suffer from an unstable disease
  • Any incidental finding on the Polysomnography reference system, happening during the study recording, that interferes with eligibility (probable moderate/severe undiagnosed OSA)
  • Subjects who may experience fitting difficulties with the headband, including people with head circumference < 53cm, or a hairstyle impeding the sensor placement (tight braids, hair extension, dreadlocks…) as determined by the investigator.

Sites / Locations

  • Biotrial Inc
  • Biotrial Rennes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dreem + PSG

Arm Description

Outcomes

Primary Outcome Measures

Performance of the automatic sleep stage scoring of the Dreem 3 System compared to the consensus of 3 independent certified sleep scorers realized on the polysomnography signal.

Secondary Outcome Measures

TST (Total Sleep Time)
Total time (in minutes) the subject spends asleep (TST) as automatically determined by the Dreem 3 System compared to the TST determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
SE (Sleep Efficiency)
Sleep efficiency (%) as automatically determined by the Dreem 3 System compared to the sleep efficiency determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
SOL (Sleep Onset Latency)
Sleep Onset Latency (in minutes) as automatically determined by the Dreem 3 System compared to the sleep onset latency determined by the consensus of 3 certified sleep scorers's scoring of the subject's PSG record from the same night.
LPS (Latency to Persistent Sleep)
Latency to Persistent Sleep (in minutes) as automatically determined by the Dreem 3 System compared to the latency to persistent sleep determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
WASO (Wake After Sleep Onset)
Total time (in minutes) the subject spends awake from sleep onset to final epoch of sleep (WASO) as automatically determined by the Dreem 3 System compared to the WASO determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Total time spent in N2 sleep stage
Total time (in minutes) the subject spends in AASM N2 sleep stage as automatically determined by the Dreem 3 System compared to the N2 time determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Total time spent in N3 sleep stage
Total time (in minutes) the subject spends in AASM N3 sleep stage as automatically determined by the Dreem 3 System compared to the N3 time determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Total time spent in REM sleep stage
Total time (in minutes) the subject spends in AASM REM sleep stage as automatically determined by the Dreem 3 System compared to the REM time determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Total time spent in N1 sleep stage
Total time (in minutes) the subject spends in AASM N1 sleep stage as automatically determined by the Dreem 3 System compared to the N1 time determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Respiratory Rate
Respiratory rate for each 30 second epoch (in cycles per minute) computed by the accelerometer of the Dreem device compared to the respiratory rate computed by the PSG sensor.

Full Information

First Posted
June 24, 2022
Last Updated
July 28, 2022
Sponsor
Dreem
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1. Study Identification

Unique Protocol Identification Number
NCT05438017
Brief Title
Performance Evaluation of the Dreem 3 System for Sleep Assessment in Patients With Insomnia
Official Title
Assessment of the Performance of the Dreem 3 System for EEG Sleep Monitoring in the Lab Setting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
July 8, 2022 (Actual)
Study Completion Date
July 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dreem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

Brief Summary
The objective of the clinical investigation is to assess the performance of the Dreem 3 System for sleep assessment compared to a FDA-cleared PSG assessment and human sleep expert scoring in a population experiencing insomnia symptoms.
Detailed Description
Subjects enrolled in the study will come to the sleep laboratory around 8 pm. Their involvement in the protocol will only require them to be equipped by the technician with Dreem 3 in addition to the PSG reference system. This involves the technician placing all the PSG electrodes on the subject's head as per normal practice, and then positioning the Dreem 3 headband so that both devices can operate simultaneously. The subject will be allowed to go to his/her room and do quiet activities (reading, film watching, chatting) prior to sleeping. At the end of the night, the technician will remove the Dreem 3 headband and the PSG. A technical quality control will be performed on the collected data in accordance with the standard operating procedures, as defined in the study protocol. Recordings that do not meet the quality control criteria will be excluded from further analysis. Subjects will receive the PSG report at the end of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Dreem, Insomnia symptoms, Sleep, Polysomnography, Performance, EEG, Sleep monitoring

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dreem + PSG
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Dreem 3 System vs PSG
Intervention Description
Dreem 3 System to be worn by each participant while undergoing in-lab sleep study with PSG.
Primary Outcome Measure Information:
Title
Performance of the automatic sleep stage scoring of the Dreem 3 System compared to the consensus of 3 independent certified sleep scorers realized on the polysomnography signal.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
TST (Total Sleep Time)
Description
Total time (in minutes) the subject spends asleep (TST) as automatically determined by the Dreem 3 System compared to the TST determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Time Frame
Day 1
Title
SE (Sleep Efficiency)
Description
Sleep efficiency (%) as automatically determined by the Dreem 3 System compared to the sleep efficiency determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Time Frame
Day 1
Title
SOL (Sleep Onset Latency)
Description
Sleep Onset Latency (in minutes) as automatically determined by the Dreem 3 System compared to the sleep onset latency determined by the consensus of 3 certified sleep scorers's scoring of the subject's PSG record from the same night.
Time Frame
Day 1
Title
LPS (Latency to Persistent Sleep)
Description
Latency to Persistent Sleep (in minutes) as automatically determined by the Dreem 3 System compared to the latency to persistent sleep determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Time Frame
Day 1
Title
WASO (Wake After Sleep Onset)
Description
Total time (in minutes) the subject spends awake from sleep onset to final epoch of sleep (WASO) as automatically determined by the Dreem 3 System compared to the WASO determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Time Frame
Day 1
Title
Total time spent in N2 sleep stage
Description
Total time (in minutes) the subject spends in AASM N2 sleep stage as automatically determined by the Dreem 3 System compared to the N2 time determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Time Frame
Day 1
Title
Total time spent in N3 sleep stage
Description
Total time (in minutes) the subject spends in AASM N3 sleep stage as automatically determined by the Dreem 3 System compared to the N3 time determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Time Frame
Day 1
Title
Total time spent in REM sleep stage
Description
Total time (in minutes) the subject spends in AASM REM sleep stage as automatically determined by the Dreem 3 System compared to the REM time determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Time Frame
Day 1
Title
Total time spent in N1 sleep stage
Description
Total time (in minutes) the subject spends in AASM N1 sleep stage as automatically determined by the Dreem 3 System compared to the N1 time determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Time Frame
Day 1
Title
Respiratory Rate
Description
Respiratory rate for each 30 second epoch (in cycles per minute) computed by the accelerometer of the Dreem device compared to the respiratory rate computed by the PSG sensor.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects must be ≥ 22 and ≤ 70 years old inclusive. Able to read, understand and sign an informed consent form. Subjects with stable disease or/and taking stable medications for at least 2 months can be included under Principal Investigator or Sub-Investigator discretion Self-reported insomnia symptoms (by means of a questionnaire completed by the participant before their visit to the sleep lab) as defined by International Classification of Sleep Disorders, third edition (ICSD-3), confirmed by a clinician. Exclusion Criteria: Female subjects who are pregnant, or breastfeeding. Subject under 22 and above 70 years old inclusive. Not able to read, understand and sign an informed consent form Subjects with BMI ≥ 40 Taking medications that induce somnolence or wakefulness, or that can interfere with sleep recording: If the subject is taking OTC medications that can induce somnolence or wakefulness, he/she must not take it the day of the measurement. Prescription only drugs that induce somnolence or wakefulness must be stopped one week before, as PI or Sub-I discretion and/or review with subject's physician. Subjects previously diagnosed with Obstructive Sleep Apnea (OSA), REM Sleep Disorder, Narcolepsy, Hypersomnia, or significant difficulty breathing due to underlying condition(s), or subjects diagnosed with Central Nervous System (CNS) disease. Subjects that suffer from an unstable disease Any incidental finding on the Polysomnography reference system, happening during the study recording, that interferes with eligibility (probable moderate/severe undiagnosed OSA) Subjects who may experience fitting difficulties with the headband, including people with head circumference < 53cm, or a hairstyle impeding the sensor placement (tight braids, hair extension, dreadlocks…) as determined by the investigator.
Facility Information:
Facility Name
Biotrial Inc
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Biotrial Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Performance Evaluation of the Dreem 3 System for Sleep Assessment in Patients With Insomnia

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