Trials / Completed
CompletedNCT04364191
Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- University of Pennsylvania · Academic / Other
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Accepted
Summary
Insomnia symptoms in older adults with mild cognitive impairment represent a significant public health burden in terms of impaired quality of life, risks from untreated insomnia, and risks from pharmaceutical insomnia treatment. To address the limitations in the most effective non-pharmacological treatments for insomnia in older adults with mild cognitive impairment, a randomized pilot study will be conducted to test a brief (4 week), tablet-based, personalized, multicomponent behavioral sleep intervention for insomnia, compared to a sleep education control, in this at-risk group. The findings of the proposed project will inform future, larger scale clinical trials and may provide a novel and innovative way for older adults with mild cognitive impairment to achieve better sleep and health-related quality of life outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Multicomponent Behavioral Sleep Intervention for Insomnia | The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night. |
| BEHAVIORAL | Active Control | The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. |
Timeline
- Start date
- 2021-05-13
- Primary completion
- 2022-08-30
- Completion
- 2022-08-30
- First posted
- 2020-04-28
- Last updated
- 2024-05-29
- Results posted
- 2024-05-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04364191. Inclusion in this directory is not an endorsement.