Extending Sleep to Reverse Metabolic Syndrome in Middle-aged Adults: Acceptability and Feasibility of a Sleep Intervention

Study Overview
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Brief Summary
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This pilot study will test acceptability and feasibility of a sleep extension intervention in community dwelling, short sleeping, racially/ethnically diverse middle aged adults with Metabolic Syndrome (METs). Baseline sleep habits will be assessed and used to guide individualized strategies to extend sleep. A 1-group pre-test, post-test study design will test the efficacy of this 18 week study (2 weeks of baseline data collection, 1 week of study intervention planning, 12 weeks of sleep intervention planning, 12 weeks of sleep intervention delivery, final follow up 3 weeks after last day of the 12 week intervention) on sleep duration, MetS factors (waist circumference, blood pressure, fasting glucose, trigycerides, HDL-c), MetS risk behaviors (poor affective well-being, fatigue) and self regulation. Socio-ecological barriers and facilitators to the intervention will be identified using a quantitative and qualitative approach.

Official Title
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Extending Sleep to Reverse Metabolic Syndrome in Middle-aged Adults: Acceptability and Feasibility of a Sleep Intervention

Conditions
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Sleep, Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Self- management for adequate sleep intervention (SASI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than or equal to 40 years of age and less than or equal to 60 years of age. Objectively confirmed MetS defined by three or more of the following: waist circumference greater than 120cm (men) or 88cm (women), blood pressure greater than or equal to 135 mmHg systolic or greater than or equal to 85 mmHg diastolic or antihypertensive medication use, fasting glucose greater than or equal to 110 mg/dL or insulin or oral hypoglycemic medication use, serum triglycerides greater than or equal to 150mg/dL or hypertriglyceridia medication use, HDL-c less than 40mg/dL (women) or less than 50 mg/dL (men) or medication use for low HDL-c1. MetS was selected because individuals with MetS are at high risk for multiple chronic conditions35. No obstructive sleep apnea. Accelerometry confirmed short sleep (average work day sleep less than or equal to 6 hours/night). English speaking. Exclusion Criteria: Pregnancy/lactation Current chemotherapy treatments Alcohol abuse/dependence Night shift or shift work (previous 2 months) trans-meridian travel (previous 4 weeks), planned shift work or trans-meridian travel during intervention period Insomnia Moderate-severe or severe depression Sleep-promoting medications Habitual napping, defined as 2 naps per day or > 90 minutes of napping on 3 or more days of the week.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SASI<br>Sleep Diaries (daily) Fitbit 24/7 Phone/videoconference (weekly with study team) Epworth Sleepiness Scale (weekly) PROMIS fatigue scale-morning (weekly) PROMIS fatigue scale-evening (weekly) | Behavioral: Self- management for adequate sleep intervention (SASI)<br>* Bedtimes and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains >90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of acceptability Pre-Intervention evaluated by the percentage of participants rating SASI as acceptable, neutral, unacceptable | Acceptable (overall acceptability survey scores greater than 21), neutral (overall acceptability survey scores equal to 21), and unacceptable (overall acceptability survey scores less than 21) at each of two time points | 0 Months | 
| Measure of acceptability Post Intervention evaluated by the percentage of participants rating SASI as acceptable, neutral, unacceptable | Acceptable (overall acceptability survey scores greater than 21), neutral (overall acceptability survey scores equal to 21), and unacceptable (overall acceptability survey scores less than 21) at each of two time points (pre- intervention and post intervention). | 4 Months |