NCT05771844
Home Sleep Therapy for Older Adults With MCI
Recruiting
NAAges 40–85InterventionalTreatmentBrain Electrophysiology Laboratory Company
~60 participants
Updated 2025-02-17 on ClinicalTrials.gov
What's tested:Transcranial Electrical Stimulation
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device Usability
Measured over Collected each day they use the Sleep WISP system, for three sessions over 10 days during Phase I of the study.
+2 more outcomes measured
Conditions
Where it's being run
2 sites across 2 statesNorth Carolina1
Oregon1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
For participant with Amnestic MCI, the inclusion age range is 55-85 years old.
For healthy volunteers without MCI, the inclusion age range is 40-80 years old.
Exclusion
History of seizures
History of epilepsy
History of mod/severe brain injury or trauma (including neurosurgery)
History or presence of significant neurological disease such as Parkinson
History of Electroconvulsive Therapy (ECT)
Presence of severe insomnia
Presence of untreated sleep apnea
Presence of severe anxiety or depression
Medications that may affect the EEG
History of stroke
Sensitivity or allergy to lidocaine or silver
Presence of active suicidal ideation
Presence of metal in head or implants or medication infusion device
Pregnancy
Adverse reaction to TMS
What this trial measures
- Device UsabilityCollected each day they use the Sleep WISP system, for three sessions over 10 days during Phase I of the study.
Criteria for success: the prototype is safe for all participants, and it is usable at home by 80% of adults with MCI. Specific outcome ratings (5-point Lickert scale) will be obtained for (1) ability to clean the device, (2) ability to apply the device, (3) ability to turn on the tablet (launching the dedicated software); (4) ability to start treatment; (5) ability to complete treatment.
- Duration of N3 SleepMeasured during the nights of sleep (typically 8 hours) across both phases of the study
Duration in minutes of N3 sleep
- Percentage of N3 SleepMeasured during the nights of sleep (typically 8 hours) across both phases of the study
Percentage of the night's sleep spent in N3