Study of Bedroom Environment Sleep Intervention at Home for Older Adults Living Alone With Memory Concerns

StatusNot Yet Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 7 months later Jun 2028 → Feb 2029
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Record History

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  1. Notable Primary and study completion pushed from Jun 2028 to Feb 2029
    • Start date: Oct 2026 to Feb 2027
    • Eligibility criteria expanded, about 11 words
  2. Notable Start date: Jun 2026 to Oct 2026v3
  3. Minor Re-verified, no change to tracked fieldsv2
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
This is an eight-week pilot research study designed to test whether simple changes to the bedroom environment along with brief sleep hygiene strategies, can improve sleep in older adults who live alone, have memory concerns, and experience insomnia symptoms. Older adults may be eligible to participate. The intervention will take 8 weeks, which includes 1-2 in-person visits from the research team at the participant's residence (evaluate the bedroom environment, install participant-agreed bedroom changes, deliver target sleep hygiene strategy) and 2 virtual or telephone calls (support environmental and sleep hygiene strategies) over 8 weeks. Sleep and environment data will be collected at screening/baseline, mid-intervention (4-week) and post-intervention (8-week)
Trial Details
NCT Number NCT07440498
Lead Sponsor Johns Hopkins University
Collaborators: National Institute on Aging (NIA)
Conditions
(from sponsor)
Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), Insomnia
Related terms Cognitive Dysfunction, Sleep Initiation and Maintenance Disorders
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov