N/A
N=27
Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment
Mild Cognitive Impairment · Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT04364191 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Sleep Latency — 28.51; 47.06 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multicomponent Behavioral Sleep Intervention for Insomnia (Behavioral); Active Control (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Latency |
25.39; 35.92 | — |
| PRIMARY Sleep Latency |
25.39; 35.92 | — |
| PRIMARY Health Related Quality of Life (HRQOL) |
55.83; 54.58 | — |
| PRIMARY Health Related Quality of Life (HRQOL) |
55.83; 54.58 | — |
| SECONDARY Wake After Sleep Onset (WASO) |
29.30; 35.21 | — |
| SECONDARY Wake After Sleep Onset (WASO) |
29.30; 35.21 | — |
| SECONDARY Total Sleep Time (TST) |
381.38; 340.38 | — |
| SECONDARY Total Sleep Time (TST) |
381.38; 340.38 | — |
| SECONDARY Sleep Efficiency (SE) |
77; 66 | — |
| SECONDARY Sleep Efficiency (SE) |
77; 66 | — |
| SECONDARY Self- Reported Insomnia Symptoms |
9.42; 11.83 | — |
| SECONDARY Self- Reported Insomnia Symptoms |
9.42; 11.83 | — |
| SECONDARY Self-reported Sleep Quality |
8.5; 10.17 | — |
| SECONDARY Self-reported Sleep Quality |
8.5; 10.17 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 1) age 55 and older
- 2) mild cognitive impairment (MCI) The Telephone Interview for Cognitive Status 13-item modified (TICS-M) version will be used to screen participants for eligibility in the study. We will include participants with TICS-M scores of 28-36, based off ranges and optimal cutpoints determined in various studies.
- 3) have insomnia symptoms a)answer yes to "Do you have trouble falling asleep, staying asleep, awakening too early, or have unrefreshing sleep" and b) have subjective sleep diary evidence of insomnia, with an average sleep onset latency >30 min or wakefulness after sleep onset of >60 min during the one week pre-treatment assessment
- 4) live in the community
- 5) speak English as primary language
Exclusion Criteria
- 1) Presence of moderate to severe cognitive impairment defined as TICS score <28
- 2) Visual or manual dexterity impairment that prevents them from pressing yes/no buttons, or selecting a number at 24 point font
- 3) Current sedative-hypnotic or other sleep aid use on a regular or as needed schedule within the prior three months
- 4) Presence of an acute medical or psychiatric condition which, in the judgement of the research team, would interfere with the subject's ability to realistically follow the study protocol
Data sourced from ClinicalTrials.gov (NCT04364191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.