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

NCT ID: NCT03599388

Last Updated: 2020-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-04-02

Brief Summary

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.

Conditions

Sleep; Metabolic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

SASI

• 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)

Group Type: EXPERIMENTAL

Self- management for adequate sleep intervention (SASI)

Intervention Type: BEHAVIORAL

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

Interventions

Self- management for adequate sleep intervention (SASI)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Malone

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

18-00396

Identifier Type: -

Identifier Source: org_study_id