Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04896775

NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers

Led by University of South Florida · Updated on 2026-04-30

100

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver and PWD dyads). We will measure both the short term (post-treatment) and long term (6 and 12 months) effects of the intervention on CG sleep, arousal, inflammation, health, mood, burden and cognitive function, and PWD sleep.

CONDITIONS

Official Title

NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Caregivers aged 18 years or older
  • Caregivers living with a person with dementia
  • Willingness to be randomized in the study
  • Ability to read and understand English
  • Diagnosis of insomnia
  • No use of prescribed or over-the-counter sleep medications for 1 or more months or stable use for 6 or more months
  • Insomnia complaints lasting 6 or more months
  • Adequate opportunity and conditions for sleep
  • At least one symptom: difficulty falling asleep, staying asleep, or waking too early
  • Daytime problems due to insomnia affecting mood, cognition, social, or work activities
  • Sleep diaries showing more than 30 minutes of sleep onset delay or wake after sleep onset on 3 or more nights
  • Persons with dementia with probable or possible Alzheimer's Disease confirmed by self-report or healthcare provider
  • Persons with dementia having one or more nighttime behavior problems at least 3 nights per week
  • Persons with dementia able to tolerate actigraphy monitoring
  • Persons with dementia not using sleep medications for 1 or more months or stable use for 6 or more months
  • Persons with dementia without untreated sleep disorders that contraindicate CBT-I (e.g., apnea)
  • Persons with dementia scoring below 32 on Sleep Apnea scale and Sleep Disorders Questionnaire
Not Eligible

You will not qualify if you...

  • Caregivers unable to provide informed consent
  • Caregivers with cognitive impairment (Telephone Interview for Cognitive Status score below 25)
  • Caregivers with sleep disorders other than insomnia (e.g., apnea with apnea/hypopnea index above 15)
  • Caregivers with bipolar disorder or seizure disorder
  • Caregivers with major psychiatric illnesses other than depression or anxiety, including suicidal or psychotic conditions
  • Caregivers with severe untreated psychiatric conditions
  • Caregivers using psychotropic or other medications affecting sleep, such as beta-blockers
  • Caregivers receiving non-drug treatments for sleep or mood outside this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of South Florida

Tampa, Florida, United States, 33612

Actively Recruiting

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Research Team

C

Christina S McCrae

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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