Clinical trial NCT05627388: Feasibility Study of At-Home EEG Monitoring for Hypersomnia
Official title: Feasibility Study of Utilizing At-Home Electroencephalography Monitoring for Diagnosing and Treatment Monitoring of Hypersomnia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypersomnia
Narcolepsy
Keywords: At-Home Sleep EEG-Based Monitoring
Dreem 3 System
Polysomnography (PSG)
Multiple Sleep Latency Test (MSLT)
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Dreem SAS
First posted: 2022-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measuring sleep and wake events for the evaluation of hypersomnia disorders
timeFrame: 2 weeks
measure: Performance of the automatic scoring of the Dreem 3 compared to the consensus of 5 certified sleep scorers realized on the polysomnography, during PSG and MSLT
timeFrame: 2 days
measure: Measuring Treatment Efficacy with At-home EEG Monitoring (Dreem 3 System)
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
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