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

NCT04364191 | Completed Results

• 2 other identifiers: 832826K23NR018487
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Insomnia

Outcome Measures

Primary Outcomes (4)

• 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)

• Sleep Latency

  time it takes a person to fall asleep, starting from first intention to sleep; measured by sleep diary

  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.

  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.

  3 months post intervention

Secondary Outcomes (10)

• Wake After Sleep Onset (WASO)

  immediately post intervention (4-5weeks after the start of the intervention)

• Wake After Sleep Onset (WASO)

  3 months post intervention

• Total Sleep Time (TST)

  immediately post intervention

• Total Sleep Time (TST)

  3 months post intervention

• Sleep Efficiency (SE)

  immediately post intervention

Other Outcomes (2)

• Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis

  Immediately post intervention

• Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis

  3 months post intervention

Study Arms (2)

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.

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).

Behavioral: Active Control

Interventions

Multicomponent Behavioral Sleep Intervention for Insomnia BEHAVIORAL

The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.

Intervention Arm

Active Control BEHAVIORAL

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.

Control Arm

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) age 55 and older
• \) 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.
• \) 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
• \) live in the community
• \) speak English as primary language

You may not qualify if:

• \) Presence of moderate to severe cognitive impairment defined as TICS score \<28
• \) Visual or manual dexterity impairment that prevents them from pressing yes/no buttons, or selecting a number at 24 point font
• \) Current sedative-hypnotic or other sleep aid use on a regular or as needed schedule within the prior three months
• \) 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

Dried blood spot analysis was changed into a feasibility measure, given the low responses.

Results Point of Contact

• Title: Miranda McPhillips
• Organization: University of Pennsylvania

mvarr@nursing.upenn.edu

215-898-8281

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 28, 2020
• Study Start: May 13, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: May 29, 2024
• Results First Posted: May 29, 2024

Record last verified: 2024-05

Locations

US (1)