Phase
Condition
Insomnia
Restless Leg Syndrome
Sleep Disorders
Treatment
Dreem 3S recording
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must be ≥ 18 years old.
Patients must be scheduled for an MSLT for a potential diagnosis of hypersomnia (ArmA only).
Patients are able/willing to consent and willing to undergo the nocturnal PSG, MSLT,and Dreem 3S monitoring described in the protocol.
(for Known NT1 arm [Arm B] only) Deemed safe to discontinue prohibited medicationsas per protocol.
(for Known NT1 arm [Arm B] only) Agree to discontinue driving and operating heavymachinery while untreated for their condition and according to the PI's judgement.
Exclusion
Exclusion Criteria:
Patients under 18 years old.
If a patient is taking a wake promoting drug and is unsafe to temporarily reduce ordiscontinue the drug during the 2 weeks prior to nocturnal PSG and MSLT due to theiroccupation, need to drive or operate heavy machinery, role as a primary caretaker,medical risk of temporarily discontinuing from drug therapy, or any other reason atthe discretion of the subject's treating physician or study physicians/PIs.
Patients suffering from mental and/or physical disorders that could interfere withthe study protocol or the interpretation of the results (exclusion based on clinicaljudgment).
Shift workers or patients working unusual hours will be excluded. 5. Patients with ahistory of stroke or epilepsy.
Patients with an implanted hypoglossal nerve stimulator or a diagnosis of moderateto severe sleep apnea (Apnea-Hypopnea Index (AHI) 3% >15) not adherent on positiveairway pressure therapy (usage 30-day window prior to enrollment date reveals <70%days use at least hours; patients treated with non-PAP treatments will not beeligible).
Patients who are unable to sign an informed consent form, or unable to have a legalguardian who is able to sign along with the patient's assent.
Patients who are deemed ineligible by the site PI or treating physician for anyother reason.
Study Design
Study Description
Connect with a study center
Kaiser Permanente Fontana Medical Center
Fontana, California 92335
United StatesActive - Recruiting
Stanford University
Redwood City, California 94063
United StatesSite Not Available
Sleep Insights Medical Associates PLLC
Rochester, New York 14623
United StatesActive - Recruiting
Intrepid Research
Cincinnati, Ohio 45245
United StatesActive - Recruiting
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