NCT04896775 · RECRUITING
NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers
This trial is testing two web-based behavioral programs, NiteCAPP CARES and NiteCAPP SHARES, designed to help dementia caregivers in rural areas sleep better. Researchers will track sleep quality, mood, inflammation, and cognitive function in caregivers over 12 months, and also monitor sleep in the person with dementia they care for. This is a Phase NA trial, meaning it is evaluating real-world effectiveness of an already-developed behavioral tool.
Eligibility criteria
Inclusion: Caregiver Eligibility. Inclusion criteria: 1. 18+ yrs, 2. CG living with PWD, 3. willing to be randomized, 4. read/understand English, 5. insomnia diagnosis, 6. no prescribed or over the counter sleep meds for 1+ mo, or stabilized 6+ mos. * Insomnia: 1. complaints for 6+ mos, 2. adequate opportunity and circumstances for sleep, 3. 1+ of the following: difficulty falling asleep, staying asleep or waking too early, 4. daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, 5. baseline diaries indicate >30 mins of sleep onset latency or wake after sleep onset on 3+ nts. PWD Eligibility. 1. probable/possible Alzheimer's Disease (self-report or primary care provider written confirm), 2. 1+ problem on Nighttime Behavior Inv. 3+ nts/wk, 3. tolerate actigraphy, 4. no sleep meds 1+ mo or stabilized 6+ mos, 5. untreated sleep disorder for which CBT-I is not recommended (e.g., apnea), 6. scoring \<32 on Sleep Apnea scale, Sleep Disorders Ques. Exclusion: CG Exclusion criteria: 1. unable to consent, 2. cognitive impairment [Telephone Interview for Cognitive Status (TICS) \<25], 3. sleep disorder other than insomnia [i.e., apnea (apnea/hypopnea index-AHI >15)], 4. bipolar or seizure disorder, 5. other major psychopathology except depression or anxiety (e.g., suicidal, psychotic), 6. severe untreated psychiatric comorbidity, 7. psychotropic or other medications (e.g., beta-blockers) that alter sleep, 8. non-pharmacological tx for sleep or mood outside current trial.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-04-01