Insomnia, Mild Cognitive Impairment
Conditions
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.
Interventions
BEHAVIORALMulticomponent Behavioral Sleep Intervention for Insomnia
The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
BEHAVIORALActive 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.
Sponsors
National Institute of Nursing Research (NINR)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life (HRQOL) | 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. |
| Sleep Latency | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wake After Sleep Onset (WASO) | 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 |
| Total Sleep Time (TST) | 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 |
| Self-reported Sleep Quality | immediately post intervention | measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes) |
| Self- Reported Insomnia Symptoms | immediately post intervention | measured with the Insomnia Severity Index; score ranges from 0-28, with higher scores indicating more insomnia symptoms (thus worse outcomes) |
| Sleep Efficiency (SE) | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis | 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. |
Countries
United States
Participant flow
Recruitment details
Screened 180 participants
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm 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.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night. | 13 |
| Control Arm 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).
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. | 14 |
| Total | 27 |
Baseline characteristics
| Characteristic | Total | Intervention Arm | Control Arm |
|---|---|---|---|
| 36-Item Short Form Survey (SF-36) | 59.07 units on a scale STANDARD_DEVIATION 27.63 | 59.23 units on a scale STANDARD_DEVIATION 34.02 | 58.93 units on a scale STANDARD_DEVIATION 21.41 |
| Age, Continuous | 65.63 years STANDARD_DEVIATION 6.39 | 65.93 years STANDARD_DEVIATION 7.13 | 65.31 years STANDARD_DEVIATION 5.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 13 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Insomnia Severity Index | 13.89 scores on a scale STANDARD_DEVIATION 4.47 | 13.23 scores on a scale STANDARD_DEVIATION 4.17 | 14.5 scores on a scale STANDARD_DEVIATION 4.8 |
| Number of Participants who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis | 20 Participants | 11 Participants | 9 Participants |
| Pittsburgh Sleep Quality Index | 10.37 score on a scale STANDARD_DEVIATION 2.62 | 9.85 score on a scale STANDARD_DEVIATION 2.61 | 10.86 score on a scale STANDARD_DEVIATION 2.63 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 8 Participants | 6 Participants |
| Sex: Female, Male Female | 22 Participants | 10 Participants | 12 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 2 Participants |
| subjective sleep efficiency | 67.90 percentage STANDARD_DEVIATION 11.94 | 70 percentage STANDARD_DEVIATION 12 | 65 percentage STANDARD_DEVIATION 11 |
| subjective sleep latency | 44.09 minutes STANDARD_DEVIATION 29.95 | 41.42 minutes STANDARD_DEVIATION 33.1 | 46.57 minutes STANDARD_DEVIATION 27.73 |
| subjective total sleep time | 341.14 minutes STANDARD_DEVIATION 74.36 | 346.27 minutes STANDARD_DEVIATION 85.42 | 336.00 minutes STANDARD_DEVIATION 64.54 |
| subjective wake after sleep onset | 45.63 minutes STANDARD_DEVIATION 34.79 | 44.85 minutes STANDARD_DEVIATION 28.38 | 46.30 minutes STANDARD_DEVIATION 40.56 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
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.
Time frame: immediately post-intervention (4-5weeks after the start of the intervention)
Population: lost one intervention participant and one control participant to immediate follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Health Related Quality of Life (HRQOL) | 60.83 score on a scale | Standard Deviation 31.1 |
| Control Arm | Health Related Quality of Life (HRQOL) | 58.08 score on a scale | Standard Deviation 20.97 |
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.
Time frame: 3 months post intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Health Related Quality of Life (HRQOL) | 55.83 score on a scale | Standard Deviation 29.99 |
| Control Arm | Health Related Quality of Life (HRQOL) | 54.58 score on a scale | Standard Deviation 22.71 |
Primary
Sleep Latency
time it takes a person to fall asleep, starting from first intention to sleep, measured by sleep diary
Time frame: immediately post-intervention (4-5weeks after the start of the intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Sleep Latency | 28.51 minutes | Standard Deviation 31.18 |
| Control Arm | Sleep Latency | 47.06 minutes | Standard Deviation 34.61 |
Primary
Sleep Latency
time it takes a person to fall asleep, starting from first intention to sleep; measured by sleep diary
Time frame: 3 months post intervention
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Sleep Latency | 25.39 minutes | Standard Deviation 27.02 |
| Control Arm | Sleep Latency | 35.92 minutes | Standard Deviation 32.44 |
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)
Time frame: immediately post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Self- Reported Insomnia Symptoms | 12 score on a scale | Standard Deviation 10.67 |
| Control Arm | Self- Reported Insomnia Symptoms | 12.5 score on a scale | Standard Deviation 4.75 |
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)
Time frame: 3 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Self- Reported Insomnia Symptoms | 9.42 score on a scale | Standard Deviation 4.21 |
| Control Arm | Self- Reported Insomnia Symptoms | 11.83 score on a scale | Standard Deviation 4.86 |
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)
Time frame: 3 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Self-reported Sleep Quality | 8.5 score on a scale | Standard Deviation 2.68 |
| Control Arm | Self-reported Sleep Quality | 10.17 score on a scale | Standard Deviation 1.75 |
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)
Time frame: immediately post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Self-reported Sleep Quality | 8.83 score on a scale | Standard Deviation 2.68 |
| Control Arm | Self-reported Sleep Quality | 10.29 score on a scale | Standard Deviation 2.76 |
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
Time frame: immediately post intervention
Population: lost one intervention participant and one control participant to immediate follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Sleep Efficiency (SE) | 77 percentage of time asleep | Standard Deviation 12 |
| Control Arm | Sleep Efficiency (SE) | 68 percentage of time asleep | Standard Deviation 14 |
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
Time frame: 3 months post intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Sleep Efficiency (SE) | 77 percentage of time spent asleep | Standard Deviation 13 |
| Control Arm | Sleep Efficiency (SE) | 66 percentage of time spent asleep | Standard Deviation 17 |
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
Time frame: 3 months post intervention
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Total Sleep Time (TST) | 381.38 minutes | Standard Deviation 70.46 |
| Control Arm | Total Sleep Time (TST) | 340.38 minutes | Standard Deviation 90.11 |
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
Time frame: immediately post intervention
Population: lost one intervention participant and one control participant to immediate follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Total Sleep Time (TST) | 368.78 minutes | Standard Deviation 90.03 |
| Control Arm | Total Sleep Time (TST) | 361.43 minutes | Standard Deviation 70.86 |
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
Time frame: 3 months post intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Wake After Sleep Onset (WASO) | 29.30 minutes | Standard Deviation 33.06 |
| Control Arm | Wake After Sleep Onset (WASO) | 35.21 minutes | Standard Deviation 43.57 |
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
Time frame: immediately post intervention (4-5weeks after the start of the intervention)
Population: lost one intervention participant and one control participant to immediate follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Wake After Sleep Onset (WASO) | 29.57 minutes | Standard Deviation 33.7 |
| Control Arm | Wake After Sleep Onset (WASO) | 37.25 minutes | Standard Deviation 32.49 |
Other Pre-specified
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.
Time frame: Immediately post intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis | 10 Participants |
| Control Arm | Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis | 4 Participants |
Other Pre-specified
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.
Time frame: 3 months post intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis | 8 Participants |
| Control Arm | Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis | 6 Participants |