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Completed

NCT Number: NCT04364191

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

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Dyssomnias Insomnia Mental Disorders Nervous System Diseases Neurocognitive Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multicomponent Behavioral Sleep Intervention for Insomnia

Behavioral

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

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.

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Secondary outcomes

  1. Wake After Sleep Onset (WASO)

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

    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

  2. Wake After Sleep Onset (WASO)

    Time frame: 3 months post intervention

    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. Total Sleep Time (TST)

    Time frame: immediately post intervention

    Actual time (in minutes) a person is asleep during the nighttime sleep period; derived from actigraphy monitoring; normal sleep ranges from 420-480 minutes

  4. Total Sleep Time (TST)

    Time frame: 3 months post intervention

    Actual time (in minutes) a person is asleep during the nighttime sleep period; derived from actigraphy monitoring; normal sleep ranges from 420-480 minutes

  5. Sleep Efficiency (SE)

    Time frame: immediately post intervention

    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

  6. Sleep Efficiency (SE)

    Time frame: 3 months post intervention

    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

  7. Self- Reported Insomnia Symptoms

    Time frame: immediately post intervention

    measured with the Insomnia Severity Index; score ranges from 0-28, with higher scores indicating more insomnia symptoms (thus worse outcomes)

  8. Self- Reported Insomnia Symptoms

    Time frame: 3 months post intervention

    measured with the Insomnia Severity Index; score ranges from 0-28, with higher scores indicating more insomnia symptoms (thus worse outcomes)

  9. Self-reported Sleep Quality

    Time frame: immediately post intervention

    measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes)

  10. Self-reported Sleep Quality

    Time frame: 3 months post intervention

    measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes)

Other outcomes

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

    Time frame: Immediately post intervention

    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.

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

    Time frame: 3 months post intervention

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: MBSI-I

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2020
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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