P20 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

Treatments

Behavioral: Week 2 Intervention

Behavioral: Sleep Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03596983

18-00707

Details and patient eligibility

About

This pilot study will test the acceptability and feasibility of a sleep extension intervention in community-dwelling, short-sleeping, racially/ethnically diverse middle-aged adults with MetS. Baseline sleep habits will be assessed and used to guide individualized strategies to extend sleep. A 1-group pretest-posttest 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 delivery, final follow up 3 weeks after last day of the 12-week intervention) on sleep duration, MetS risk behaviors (reduced physical activity, increased sedentary behavior, poor diet quality), symptoms associated with 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 approac

Enrollment

41 patients

Sex

All

Ages

35 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Greater than or equal to 35 years of age and less than or equal to 60 years of age. Middle aged adults have the highest prevalence of short sleep compared to other stages of adulthood.
Objectively confirmed MetS defined by three or more of the following: a) waist circumference greater than 120cm (men) or 88cm (women), b) blood pressure greater than or equal to 135 mmHg systolic or greater than or equal to 85 mmHg diastolic or antihypertensive medication use, c) fasting glucose greater than or equal to 110 mg/dL or insulin or oral hypoglycemic medication use, d) serum triglycerides greater than or equal to 150mg/dL or hypertriglyceride medication use, e) 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 conditions.
Accelerometry confirmed short sleep (average work day sleep less than or equal to 6.5 hours/night). Self-reported sleep may overestimate sleep duration. This will ensure that participants will have short sleep patterns that are associated with MetS outcomes.
English speaking. Participants will need to demonstrate adequate English comprehension (assessed during informed consent).

Exclusion criteria

Pregnancy/lactation (self-reported). Pregnancy and lactation can disrupt habitual sleep patterns, and hormonal changes during pregnancy increase insulin resistance and may confound MetS.
Current chemotherapy treatments (self-reported). Current chemotherapy treatments may contribute to fatigue and sleep disturbances.
Alcohol abuse/dependence will be assessed with the Alcohol Use Disorders Identification Test (a measure that has demonstrated good reliability and validity). Alcohol abuse/dependence may contribute to sleep disturbances and limit the participant's ability to take part in sleep interventions.
Night shift or shift work (previous 2 months), trans-meridian travel (previous 4 weeks), or planned shift work or trans-meridian travel during intervention period (self-reported). These will be to ensure that sleep estimates from baseline represent participants' habitual sleep and to ensure adherence with the sleep intervention.
Moderate-severe or severe depression will be assessed with the PHQ-9. Moderate-severe depression or severe depression may contribute to sleep disturbances and interfere with the participant's ability to adhere to the sleep interventions.
Chronic use of sleep-promoting medications (self-reported). These may interfere with sleep patterns and limit the participant's ability to take part in the sleep interventions.
Habitual napping, defined as 2 naps per day or > 90 minutes of napping on 3 or more days of the week will be assessed during baseline with accelerometry. This will be to ensure adherence with the sleep intervention.
Diagnosed but untreated obstructive sleep apnea.