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

NYU Langone Health

Status: Completed

Conditions: Metabolic Syndrome; Sleep

Treatments: Behavioral: Self- management for adequate sleep intervention (SASI)

Study type: Interventional

Funder types: Other

Identifiers

NCT03599388

18-00396

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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:

  1. waist circumference greater than 120cm (men) or 88cm (women),
  2. blood pressure greater than or equal to 135 mmHg systolic or greater than or equal to 85 mmHg diastolic or antihypertensive medication use,
  3. fasting glucose greater than or equal to 110 mg/dL or insulin or oral hypoglycemic medication use,
  4. serum triglycerides greater than or equal to 150mg/dL or hypertriglyceridia medication use,
  5. 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

SASI

Experimental group

Description:

* 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)

Treatment:

Behavioral: Self- management for adequate sleep intervention (SASI)