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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599388
• Other study ID #: 18-00396
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: April 2, 2019

Study information

• Verified date: May 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2, 2019
• Est. primary completion date: April 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Sleep
• Syndrome

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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