Feasibility Study of At-Home EEG Monitoring for Hypersomnia

Kaiser Permanente

Status

Withdrawn

Conditions

Hypersomnia

Narcolepsy

Treatments

Other: Dreem 3 System At-Home Monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT05627388

Dreem

Details and patient eligibility

About

The central hypothesis is that home EEG monitoring (Dream 3 wearable) can be feasibly utilized for data capture of continuous sleep and wake measurements for the diagnostic evaluation and treatment monitoring of hypersomnia.

Full description

This clinical study is a prospective, single group assessment which will enroll patients who are prescribed a multiple sleep latency test (MSLT) at the Fontana Medical Sleep Center. Patients will be mailed an actigraph and a Dreem 3 system to undergo the following assessments:

1 initial in-person sleep physician encounter to discuss your sleep symptoms and review the informed consent form
1 week of actigraphy and Dreem 3 System monitoring. Actigraphy will be continuously monitored for 1 week to log sleep and wake periods. Dreem 3 System will be monitored for the first 5 nights and the last 2 days will be 48-hour continuous monitoring (i.e., day and night). Additionally, we will ask you to log your sleep/wake activity in a sleep diary.
2 consecutive in-lab sleep studies within a 24-hour period
A few reminder telephone calls for at-home monitoring

Patients will have a follow up encounter with a physician after their in-lab visit. If a diagnosis is confirmed and treatment is initiated, the patient will be asked if they want to pursue treatment follow-up for the study. Again, patient will wear the Dreem 3 System and the actigraph during 5 nights, while keeping the actigraph on during the day, to monitor sleep/wake cycle. Then, for an additional continuous 48 hour measurement, patients will wear the Dreem 3 system and actigraph (i.e. monitoring day and night). This procedure will occur once treatment is initiated as well as 1 month and 3 months after treatment initiation.

Patients will be asked to complete various sleep and quality of life questionnaires throughout the duration of the study. Questionnaires should take approximately 10-15 minutes to complete.

Sex

All

Ages

6+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients must be a Kaiser Permanente member
Patients must be ≥ 6 years old.
Patients must have an indication for Multiple Sleep Latency Test for a diagnosis of hypersomnia
Patients are able/willing to consent and willing to undergo the electrophysiological routine assessments described in the protocol
Patients do not meet any exclusion criteria

Exclusion criteria

Patients under 6 years old.
If a patient is taking a wake promoting medication and is unsafe to withdraw the medication during the 2 weeks prior to the in-lab Polysomnography/Multiple Sleep Latency study
Patients suffering from mental and/or physical disorders that could interfere with the study protocol or the interpretation of the results (exclusion based on clinical judgment)
Shift workers or patients working unusual hours will be excluded
Patients not able to sign an informed consent form