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

NCT05438017 | Completed FDA Device

• 1 other identifier: OCTAVE 3
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 2

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.

Conditions

Insomnia

Keywords

Dreem; Insomnia symptoms; Sleep; Polysomnography; Performance; EEG; Sleep monitoring

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (10)

• TST (Total Sleep Time)

  Day 1

• SE (Sleep Efficiency)

  Day 1

• SOL (Sleep Onset Latency)

  Day 1

• LPS (Latency to Persistent Sleep)

  Day 1

• WASO (Wake After Sleep Onset)

  Day 1

Study Arms (1)

Dreem + PSG

EXPERIMENTAL

Device: Dreem 3 System vs PSG

Interventions

Dreem 3 System vs PSG DEVICE

Dreem 3 System to be worn by each participant while undergoing in-lab sleep study with PSG.

Dreem + PSG

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dreem: lead

Study Sites (2)

Biotrial Inc

Newark, New Jersey, 07103, United States

Location

Biotrial Rennes

Rennes, 35000, France

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

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

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: April 21, 2022
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); US (1)