Mild Cognitive ImpairmentMBSI-INCT04364191

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

A study testing Multicomponent Behavioral Sleep Intervention for Insomnia in people with Mild Cognitive Impairment and Insomnia, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for: Mild Cognitive Impairment, Insomnia
What is being tested?: Multicomponent Behavioral Sleep Intervention for Insomnia
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 13 May 2021to 30 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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: Mild Cognitive Impairment, Insomnia
Being tested: Multicomponent Behavioral Sleep Intervention for Insomnia, Active Control
Medical subject headings: Cognitive Dysfunction, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04364191
Study group	Role	What they receive
Intervention Arm	Experimental	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. Receives: Behavioral: Multicomponent Behavioral Sleep Intervention for Insomnia
Control Arm	Active comparator	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). Receives: Behavioral: Active Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Sleep Latency
time it takes a person to fall asleep, starting from first intention to sleep, measured by sleep diary
Measured: immediately post-intervention (4-5weeks after the start of the intervention)
Sleep Latency
time it takes a person to fall asleep, starting from first intention to sleep; measured by sleep diary
Measured: 3 months post intervention
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.
Measured: immediately post-intervention (4-5weeks after the start of the intervention)
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.
Measured: 3 months post intervention

Secondary outcomes (10)

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
Measured: immediately post intervention (4-5weeks after the start of the intervention)
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
Measured: 3 months post intervention
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
Measured: immediately post intervention
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
Measured: 3 months post intervention
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
Measured: immediately post intervention
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
Measured: 3 months post intervention
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)
Measured: immediately post intervention
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)
Measured: 3 months post intervention
Self-reported Sleep Quality
measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes)
Measured: immediately post intervention
Self-reported Sleep Quality
measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes)
Measured: 3 months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 202130 Aug 2022

First posted28 Apr 2020
Study start13 May 2021
Primary completion30 Aug 2022
Study completion30 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04364191
Sponsor's protocol ID: 832826
Other IDs: K23NR018487
Acronym: MBSI-I
Status last verified: May 2024
First submitted: 15 Apr 2020
Last updated: 29 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mild Cognitive Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment
ClinicalTrials.gov ID: NCT04364191
Acronym / sponsor ID: MBSI-I / 832826
Conditions: Mild Cognitive Impairment, Insomnia
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: 13 May 2021 (actual)
Primary completion: 30 Aug 2022 (actual)
Study completion: 30 Aug 2022 (actual)
First posted: 28 Apr 2020 (actual)
Results: Posted 29 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention Arm	Experimental	Behavioral: Multicomponent Behavioral Sleep Intervention for InsomniaMeaningful 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.
Control Arm	Active comparator	Behavioral: Active ControlStudy 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).

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Multicomponent Behavioral Sleep Intervention for InsomniaThe MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.	Behavioural	Intervention Arm
Active ControlThe 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.	Behavioural	Control Arm

Primary outcome

Sleep Latency
Time frame: immediately post-intervention (4-5weeks after the start of the intervention)
time it takes a person to fall asleep, starting from first intention to sleep, measured by sleep diary
Sleep Latency
Time frame: 3 months post intervention
time it takes a person to fall asleep, starting from first intention to sleep; measured by sleep diary
Health Related Quality of Life (HRQOL)
Time frame: immediately post-intervention (4-5weeks after the start of the intervention)
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.
Health Related Quality of Life (HRQOL)
Time frame: 3 months post intervention
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.

10 secondary outcomes

Wake After Sleep Onset (WASO)
Time frame: immediately post intervention (4-5weeks after the start of the intervention)
Wake After Sleep Onset (WASO)
Time frame: 3 months post intervention
Total Sleep Time (TST)
Time frame: immediately post intervention
Total Sleep Time (TST)
Time frame: 3 months post intervention
Sleep Efficiency (SE)
Time frame: immediately post intervention
Sleep Efficiency (SE)
Time frame: 3 months post intervention
Self- Reported Insomnia Symptoms
Time frame: immediately post intervention
Self- Reported Insomnia Symptoms
Time frame: 3 months post intervention
Self-reported Sleep Quality
Time frame: immediately post intervention
Self-reported Sleep Quality
Time frame: 3 months post intervention

Results and safety

Results posted to the registry on 29 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Arm	13	12
Control Arm	14	12

Primary outcome: Sleep Latency

Time frame: immediately post-intervention (4-5weeks after the start of the intervention). Mean (Standard Deviation). Unit: minutes

Measure	Intervention Arm n = 12	Control Arm n = 13
Value	28.51 (31.18)	47.06 (34.61)

Primary outcome: Sleep Latency

Time frame: 3 months post intervention. Mean (Standard Deviation). Unit: minutes

Measure	Intervention Arm n = 12	Control Arm n = 11
Value	25.39 (27.02)	35.92 (32.44)

Population analysed: Lost one participant in intervention to follow-up; lost two participants in control arm to follow up and one had missing sleep diary data at follow up

Primary outcome: Health Related Quality of Life (HRQOL)

Time frame: immediately post-intervention (4-5weeks after the start of the intervention). Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention Arm n = 12	Control Arm n = 13
Value	60.83 (31.10)	58.08 (20.97)

Population analysed: lost one intervention participant and one control participant to immediate follow up

Primary outcome: Health Related Quality of Life (HRQOL)

Time frame: 3 months post intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention Arm n = 12	Control Arm n = 12
Value	55.83 (29.99)	54.58 (22.71)

Population analysed: Lost one participant to immediate follow-up in intervention group and one to immediate follow-up in control and one at 3 mo follow up in control group.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected at each touchpoint with participant- Weekly during the intervention, visit 2 (5 weeks after baseline), Visit 3 (17 weeks after baseline). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Arm	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Control Arm	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Limitations and caveats (from the sponsor): Dried blood spot analysis was changed into a feasibility measure, given the low responses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Multicomponent Behavioral Sleep Intervention for Insomnia in people with Mild Cognitive Impairment and Insomnia, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Latency (time frame: immediately post-intervention (4-5weeks after the start of the intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04364191.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.