Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-04

Study Completion Date

2018-11-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to evaluate the accuracy of automated sleep analysis by the Dreem dry-EEG headband and deep learning algorithm in comparison to the consensus of 5 sleep technologists' manual scoring of a gold-standard clinical polysomnogram (PSG) record in healthy adult volunteers during an overnight clinic-based sleep study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Robustness and Usability of the Dreem 3 System for at Home Sleep Monitoring in an Insomnia Population.

NCT05611099

Insomnia, Secondary Sleep Disturbance Sleep +1 more

COMPLETED NA

Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy

NCT06531876

Narcolepsy Type 1 Hypersomnia Sleep Disorder

ACTIVE_NOT_RECRUITING NA

Evaluation of e New Sleep Detection Device "Easy Sleep Monitoring"

NCT05696496

Sleep Disorder

ACTIVE_NOT_RECRUITING NA

Self-Management of Sleep Among Older Adults

NCT03837249

Sleep Disturbance

COMPLETED EARLY_PHASE1

Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ

NCT04513743

Sleep

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will enroll 25 adult volunteers who will undergo a one-night in-lab sleep study. All volunteers are first prescreened over the phone. Upon arrival at the research center, volunteers provide informed consent, are interviewed to confirm eligibility, and complete a detailed demographic, medical, health, sleep, and lifestyle survey. After the survey, participants are fitted with the PSG and the Dreem headband by the sleep technologist. During the PSG sleep study, the Dreem headband records EEG, pulse, oxygen saturation (SO2), movement, and respiratory rate.

Dreem's algorithms will be used to automatically stage the Dreem sleep data, and the results will then be compared to the consensus of 5 sleep technologists' manual scoring of the respective PSG records for the same individuals to determine the accuracy of Dreem's sleep staging algorithms.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Dreem

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy adults

Dreem

Group Type EXPERIMENTAL

Dreem

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dreem

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Capable of providing informed consent

Exclusion Criteria

* Pregnant or nursing females
* History of any severe comorbidities such as cardiac, neurologic, or psychiatric diseases/disorders in the last 12 months
* Morbid obesity (BMI \>= 40)
* Use of benzodiazepines, nonbenzodiazepine (Z-drugs), or Gammahydroxybutyrate (GHB) the day/night of the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes