Insomnia
Conditions
Brief summary
This study is a validation study to document the acceptability of the Tonic and Phasic Alertness Training (TAPAT) training program in older adults with chronic late-life insomnia. The goal of this study is to employ a computerized attention-training program, TAPAT, designed for chronic late-life insomnia in a randomized, controlled trial to assess feasibility and initial efficacy in this population.
Interventions
Sponsors
University of California, San Francisco
Posit Science Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participant must be between ages 55 and 80. * Participant must meet current diagnostic criteria for Primary Insomnia Disorder based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). * Participant with hypertension must be undergoing treatment for this condition and on a stable medication regimen for hypertension for ≥ 8 weeks prior to screening. * Participant must be a fluent English speaker * Participant must have adequate visual, auditory, and motor capacity to use computerized intervention * Participant must be willing to wear Microsoft Band 2 watch to track sleep patterns
Exclusion criteria
* Participants with cognitive impairment, delirium or dementia, or evidence of cognitive impairment from a pre-existing cause. * Participants with untreated psychiatric conditions, including substance abuse/dependence disorders, untreated obstructive sleep apnea, diagnosis of other sleep disorders (e.g., restless legs syndrome), recent hospitalization, ongoing chemotherapy or other cancer treatment, and concurrent engagement in another insomnia treatment. * Participants enrolled in another concurrent research study. * Participants who have difficulty performing assessments or comprehending or following spoken instructions, in the judgment of the screening clinician. * Participants using computer-based cognitive training programs or has used them within a month of the consent date.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep efficiency and sleep duration scores on the Pittsburg Sleep Quality Index | 4 months |
| Sleep duration obtained by actigraphy (Microsoft Band 2 watch) | 4 months |
| Sleep duration obtained by sleep diary | 4 months |
Countries
United States
Outcome results
None listed