Narcolepsy Clinical Trial
Official title:
Feasibility Study of Utilizing At-Home Electroencephalography Monitoring for Diagnosing and Treatment Monitoring of Hypersomnia
NCT number | NCT05627388 |
Other study ID # | Dreem |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2023 |
Est. completion date | April 1, 2024 |
Verified date | May 2024 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | Dreem SAS |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measuring sleep and wake events for the evaluation of hypersomnia disorders | Evaluating feasibility, quality, & patient compliance of Dreem monitoring.
The following aggregated metrics will produce an environment similar to standard care procedures for assessing hypersomnia in order to evaluate the monitoring capabilities of Dreem and actigraphy devices. Usability Questionnaires: means, standard deviations, frequencies, & scores Number, type & structure of sleep events as automatically determined by Dreem/Actigraphy devices, which are considered relevant for the initial evaluation of hypersomnia disorders by the physician Dreem compliance: median/mean hours of usage over 24 hrs % of Dreem records which pass the quality control criteria |
2 weeks | |
Primary | 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 | 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.
The stability and correlation of each sleep variable will be examined graphically and using intraclass correlation coefficients (ICC) with 95% confidence intervals (95% CI). |
2 days | |
Primary | Measuring Treatment Efficacy with At-home EEG Monitoring (Dreem 3 System) | 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 with the Dreem device. Clinical & QoL PRO: Mean change from baseline in ESS/NSS/IHSS/FOSQ10/EQ5D5L Usability Questionnaires: means, standard deviations, frequencies, & scores 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 |
3 weeks |
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