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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03599388
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Actual Duration (Months): 5
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep; Metabolic Syndrome	Behavioral: Self- management for adequate sleep intervention (SASI)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Extending Sleep to Reverse Metabolic Syndrome in Middle-aged Adults: Acceptability and Feasibility of a Sleep Intervention
• Actual Study Start Date: Nov 1, 2018
• Actual Primary Completion Date: Apr 2, 2019
• Actual Study Completion Date: Apr 2, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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)

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

Outcome Measures

Primary Outcome Measures

1. Measure of acceptability Pre-Intervention evaluated by the percentage of participants rating SASI as acceptable, neutral, unacceptable [0 Months]

   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

2. Measure of acceptability Post Intervention evaluated by the percentage of participants rating SASI as acceptable, neutral, unacceptable [4 Months]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Susan Malone, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03599388
• Other Study ID Numbers: 18-00396
• First Posted: Jul 26, 2018
• Last Update Posted: May 15, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of May 15, 2020