Phase
Condition
Insomnia
Treatment
Sleep Hygiene Education
Computerized Plasticity-Based Adaptive Cognitive Training
Clinical Study ID
Ages > 65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who are 65 years of age or older. The inclusion age of ≥ 65 is inaccordance with the FDA's Guideline for Industry Studies in Support of SpecialPopulations (Geriatrics ICH-E7), which uses 65 as its cutoff for defining thegeriatric population prone to insomnia.
Participants who have an Insomnia disorder diagnosis per DSM-V.
Participants who exhibit > 30 minutes sleep onset latency (SOL); and/or > 30 minuteswake after sleep onset (WASO).
Participants must be a US resident.
Participants who are fluent English speakers, per self-report, to ensure reasonableneuropsychological results on key assessments.
Participants must have adequate sensorimotor capacity to perform the program,including visual capacity adequate to read from a computer screen at a normalviewing distance, auditory capacity adequate to understand normal speech, and motorcapacity adequate to control a computer mouse or a tablet.
Exclusion
Exclusion Criteria:
Participants who score ≥ 4 on the Cognitive Function Index (CFI).
Participants who self-report vision or hearing difficulties that would interferewith the ability to complete the study tasks.
Participants with past or present psychosis, schizophrenia, or bipolar disorder.Participants with other untreated psychiatric disorder, including substanceabuse/dependence disorders.
Participants with a seizure disorder.
Participants with untreated obstructive sleep apnea, diagnosis of other sleepdisorders not attributable to a primary sleep regulation problem (e.g., restlesslegs syndrome).
Participants with a recent hospitalization, ongoing chemotherapy or other cancertreatment.
Participants enrolled in a concurrent clinical trial involving an investigationalpharmaceutical, nutraceutical, medical device, or behavioral treatment (CBTi) in thelast 12-months that could affect the outcome of this study, or concurrent engagementin another insomnia treatment, per self-report. However, participation in standardtreatments not known to affect sleep (e.g., occupational therapy) or use ofprescribed medications (e.g., anti-depressants) is allowable if stable onmedications for > 3 months.
Participants who are using computer-based cognitive training programs or have usedit within a month of the consent date.
Study Design
Connect with a study center
Posit Science Corporation
San Francisco, California 94111
United StatesActive - Recruiting
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