Feasibility Study of At-Home EEG Monitoring for Hypersomnia

Narcolepsy Clinical Trial

Official title: Feasibility Study of Utilizing At-Home Electroencephalography Monitoring for Diagnosing and Treatment Monitoring of Hypersomnia

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Hypersomnia
• Narcolepsy

• NCT number: NCT05627388
• Study type: Interventional
• Source: Kaiser Permanente
• Status: Withdrawn
• Phase: N/A
• Start date: February 2023
• Completion date: April 1, 2024