NCT05627388

Feasibility Study of At-Home EEG Monitoring for Hypersomnia

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypersomnia
• Narcolepsy

Interventions

Type	Name	Description
OTHER	Dreem 3 System At-Home Monitoring	Patients will be asked to wear the Dreem 3 System and actigraphy devices at home. Research support staff will teach patients how set up the device beforehand. Patients will wear Dreem and actigraph for 5 nights, while keeping the actigraph on during the day, to monitor sleep/wake cycle. Then, for an additional continuous 48hr measurement, patients will wear the Dreem and actigraph. The patient will be given 2 devices, as one device can record up to 24h of data continuously. Patients are not required to stay home during the 48hr testing period. However, patients will be instructed to refrain from participating in activities which may shift or require removal of Dreem. Patients who wish to remain home for the 48hr testing period should have adequate sustenance (i.e., groceries). Any caffeine and sleep medication intake will be logged by the patient in a sleep diary. If needed, patients will be given an off work order from work/school for the 48hr assessment.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2022-11-25
• Last updated: 2024-05-14