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Study was never started. The research protocol was redeveloped and submitted as a new study therefore we would like to close this study.
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| Name | Class |
|---|---|
| Dreem SAS | UNKNOWN |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dreem 3 System | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dreem 3 System At-Home Monitoring | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 2 weeks |
| 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 |
| 2 days |
| 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.
| 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| D001523 |
| Mental Disorders |