Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

— MBSI-I  

Official title:

Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364191
• Other study ID #: 832826
• Secondary ID: K23NR018487
• Status: Completed
• Phase: N/A
• Start date: May 13, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: May 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Insomnia
• Mild Cognitive Impairment
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Multicomponent Behavioral Sleep Intervention for Insomnia
The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis	Systemic inflammatory markers will be assayed using dried blood spots (DBS). DBS provides an easy to obtain, transport, and analyze blood source. Our Translational Core Laboratory utilizes a matrix independent platform (Mesoscale Discovery, Rockville MD), to support the assay of DBS for systemic inflammatory markers. Participants who have trouble with the finger prick will be provided with verbal assistance at sample pick-up while the researcher maintains physical distance. The outcome measure used for this study will be number of participants who complete the dried blood spot sample, as a measure of feasibility.	Immediately post intervention
Other	Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis	Systemic inflammatory markers will be assayed using dried blood spots (DBS). DBS provides an easy to obtain, transport, and analyze blood source. Our Translational Core Laboratory utilizes a matrix independent platform (Mesoscale Discovery, Rockville MD), to support the assay of DBS for systemic inflammatory markers. Participants who have trouble with the finger prick will be provided with verbal assistance at sample pick-up while the researcher maintains physical distance.	3 months post intervention
Primary	Sleep Latency	time it takes a person to fall asleep, starting from first intention to sleep, measured by sleep diary	immediately post-intervention (4-5weeks after the start of the intervention)
Primary	Sleep Latency	time it takes a person to fall asleep, starting from first intention to sleep; measured by sleep diary	3 months post intervention
Primary	Health Related Quality of Life (HRQOL)	RAND Medical Outcomes Study Short Form-36 (SF-36) is a multidomain scale that measures physical and mental components of HRQOL with eight subscales. The 8 subscales include physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health. All sub scales range from 0 to 100 (lower scores indicate worse HRQOL). For this primary analysis, we are using the general health sub scale, ranging from 0 to 100, where lower scores indicate worse HRQOL.	immediately post-intervention (4-5weeks after the start of the intervention)
Primary	Health Related Quality of Life (HRQOL)	RAND Medical Outcomes Study Short Form-36 (SF-36) is a multidomain scale that measures physical and mental components of HRQOL with eight subscales. The 8 subscales include physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health. All sub scales range from 0 to 100 (lower scores indicate worse HRQOL). For this primary analysis, we are using the general health sub scale, ranging from 0 to 100, where lower scores indicate worse HRQOL.	3 months post intervention
Secondary	Wake After Sleep Onset (WASO)	time (in minutes) a person spends awake during the night, starting from the time the person falls asleep; derived from actigraphy monitoring; more WASO indicates worse sleep	immediately post intervention (4-5weeks after the start of the intervention)
Secondary	Wake After Sleep Onset (WASO)	time (in minutes) a person spends awake during the night, starting from the time the person falls asleep; derived from actigraphy monitoring; more WASO indicates worse sleep	3 months post intervention
Secondary	Total Sleep Time (TST)	Actual time (in minutes) a person is asleep during the nighttime sleep period; derived from actigraphy monitoring; normal sleep ranges from 420-480 minutes	immediately post intervention
Secondary	Total Sleep Time (TST)	Actual time (in minutes) a person is asleep during the nighttime sleep period; derived from actigraphy monitoring; normal sleep ranges from 420-480 minutes	3 months post intervention
Secondary	Sleep Efficiency (SE)	Percent of time spent in bed that a person is asleep; calculated from actigraphy (time asleep/ time in bed)x 100%; lower SE indicates worse sleep	immediately post intervention
Secondary	Sleep Efficiency (SE)	Percent of time spent in bed that a person is asleep; calculated from actigraphy (time asleep/ time in bed)x 100%; lower SE indicates worse sleep	3 months post intervention
Secondary	Self- Reported Insomnia Symptoms	measured with the Insomnia Severity Index; score ranges from 0-28, with higher scores indicating more insomnia symptoms (thus worse outcomes)	immediately post intervention
Secondary	Self- Reported Insomnia Symptoms	measured with the Insomnia Severity Index; score ranges from 0-28, with higher scores indicating more insomnia symptoms (thus worse outcomes)	3 months post intervention
Secondary	Self-reported Sleep Quality	measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes)	immediately post intervention
Secondary	Self-reported Sleep Quality	measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes)	3 months post intervention