Feasibility Study of At-Home EEG Monitoring for Hypersomnia

Sponsor

Kaiser Permanente (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05627388

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypersomnia Narcolepsy	Other: Dreem 3 System At-Home Monitoring	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Dreem 3 System	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. Dreem's battery only lasts 24hr, so the patient will be given 2 devices for the 48hr assessment. 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.

Arm

Intervention/Treatment

Other: Dreem 3 System

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. Dreem's battery only lasts 24hr, so the patient will be given 2 devices for the 48hr assessment. 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.

Outcome Measures

Primary Outcome Measures

Feasibility of At-home EEG Monitoring (Dreem 3 System) [3 weeks]
Evaluate the feasibility of sleep and wake continuous data collection with the Dreem 3 System through patient feedback usability questionnaires. Scores will consist of a Likert scale (scores ranging from strongly agree to strongly disagree) with responses ranging from positive to negative depending on the question asked.
Dreem 3 System Hypersomnia Diagnosis [3 weeks]
For the hypersomnia diagnosis process, Dreem data in conjunction to nocturnal PSG and diurnal MSLT data will be analyzed using the following aggregated measurements: Epoch by Epoch sleep stage scoring will be analyzed by generating the 5x5 confusion matrix between Dreem automatic sleep scoring and the 5 sleep scorers' consensus rating. Endpoints for % of time in each sleep stage (N1, N2, N3, and REM + Wake), Mean Sleep Onset Latency (MSOL), Sleep Onset REM Period (SOREMP), sleep latency will be summarized using descriptive statistics and 95% confidence intervals for each of Dreem 3 System and PSG consensus ratings. The 5 certified sleep scorers' consensus for these endpoints will be calculated as the mean. The stability of each variable will be examined graphically and using intraclass correlation coefficients (ICC) with 95% confidence intervals (95% CI).
Testing Quality Measurements of At-home EEG Monitoring (Dreem 3 System) [2 weeks]
Determine the monitoring quality of the Dreem 3 System by utilizing the expertise of 5 independent sleep scorers. All of the following measurements must be aggregated to determine the monitoring quality of the Dreem 3 System. These aggregated measurements will be cross-referenced with a PSG & MSLT study: Sleep Stage W (Wake) Stage N1 (min) Stage N2 (min) Stage N3 (min) Stage REM (min) Total Sleep Time (min) WASO (min) Sleep Efficiency % Sleep Onset Latency Latency to Permanent Sleep Number of sleep stage shifts from sleep to wake epoch awakenings Time of last of any epoch of sleep: Final rise time Lights on: time when record stops Average respiration rate (breathes/min)
Measuring Treatment Efficacy with At-home EEG Monitoring (Dreem 3 System) [3 weeks]
Evaluating feasibility, quality, & patient compliance of Dreem monitoring after treatment initiation,1 month & 3 months. The following aggregated metrics will produce an environment similar to standard care procedures for assessing hypersomnia in order to evaluate the treatment efficacy of Dreem. Clinical & QoL PRO: Mean change from baseline in ESS/NSS/IHSS/FOSQ10/EQ5D5L Usability Questionnaires: means, standard deviations, frequencies, & scores Correlation between sleep events subjectively reported in the sleep diary & sleep events automatically-recorded by Dreem/Actigraphy devices Number, type & structure of sleep events as automatically determined by Dreem/Actigraphy devices, which are considered relevant for the treatment efficacy evaluation of hypersomnia by the physician Dreem compliance: median/mean hours of usage over 24 hrs % of Dreem records which pass the quality control criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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