Back to resultsMulticomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment (MBSI-I)
Primary Purpose
Mild Cognitive Impairment, Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multicomponent Behavioral Sleep Intervention for Insomnia
Active Control
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment
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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Arm
Control Arm
Arm Description
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. 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. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Outcomes
Primary Outcome Measures
Sleep latency
time it takes a person to fall asleep, starting from first intention to sleep, measured by sleep diary
Sleep latency
time it takes a person to fall asleep, starting from first intention to sleep; measured by sleep diary
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 contribute to two resulting component summaries: a mental component summary (MCS) and a physical component summary (PCS). Both PCS and MCS scores range from 0 to 100 (lower scores indicate worse HRQOL).
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 contribute to two resulting component summaries: a mental component summary (MCS) and a physical component summary (PCS). Both PCS and MCS scores range from 0 to 100 (lower scores indicate worse HRQOL).
Secondary Outcome Measures
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
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
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
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
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
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
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)
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)
self-reported sleep quality
measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes)
self-reported sleep quality
measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes)
Full Information
NCT ID
NCT04364191
First Posted
April 15, 2020
Last Updated
March 1, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT04364191
Brief Title
Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment
Acronym
MBSI-I
Official Title
Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 13, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. 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. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Intervention Type
Behavioral
Intervention Name(s)
Multicomponent Behavioral Sleep Intervention for Insomnia
Intervention Description
The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep latency
Description
time it takes a person to fall asleep, starting from first intention to sleep, measured by sleep diary
Time Frame
immediately post-intervention
Title
Sleep latency
Description
time it takes a person to fall asleep, starting from first intention to sleep; measured by sleep diary
Time Frame
3 months post intervention
Title
health related quality of life (HRQOL)
Description
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 contribute to two resulting component summaries: a mental component summary (MCS) and a physical component summary (PCS). Both PCS and MCS scores range from 0 to 100 (lower scores indicate worse HRQOL).
Time Frame
immediately post-intervention
Title
health related quality of life (HRQOL)
Description
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 contribute to two resulting component summaries: a mental component summary (MCS) and a physical component summary (PCS). Both PCS and MCS scores range from 0 to 100 (lower scores indicate worse HRQOL).
Time Frame
3 months post intervention
Secondary Outcome Measure Information:
Title
Wake after sleep onset (WASO)
Description
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
Time Frame
immediately post intervention
Title
Wake after sleep onset (WASO)
Description
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
Time Frame
3 months post intervention
Title
Total sleep time (TST)
Description
Actual time (in minutes) a person is asleep during the nighttime sleep period; derived from actigraphy monitoring; normal sleep ranges from 420-480 minutes
Time Frame
immediately post intervention
Title
Total sleep time (TST)
Description
Actual time (in minutes) a person is asleep during the nighttime sleep period; derived from actigraphy monitoring; normal sleep ranges from 420-480 minutes
Time Frame
3 months post intervention
Title
Sleep efficiency (SE)
Description
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
Time Frame
immediately post intervention
Title
Sleep efficiency (SE)
Description
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
Time Frame
3 months post intervention
Title
Self- reported insomnia symptoms
Description
measured with the Insomnia Severity Index; score ranges from 0-28, with higher scores indicating more insomnia symptoms (thus worse outcomes)
Time Frame
immediately post intervention
Title
Self- reported insomnia symptoms
Description
measured with the Insomnia Severity Index; score ranges from 0-28, with higher scores indicating more insomnia symptoms (thus worse outcomes)
Time Frame
3 months post intervention
Title
self-reported sleep quality
Description
measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes)
Time Frame
immediately post intervention
Title
self-reported sleep quality
Description
measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes)
Time Frame
3 months post intervention
Other Pre-specified Outcome Measures:
Title
Inflammatory Biomarkers including cytokines (IL-6, IL-1ß, TNF-α) and C-reactive protein (CRP)
Description
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.
Time Frame
Immediately post intervention
Title
Inflammatory Biomarkers including cytokines (IL-6, IL-1ß, TNF-α) and C-reactive protein (CRP)
Description
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.
Time Frame
3 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment
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