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

NCT03599388 | Completed

• 1 other identifier: 18-00396
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

SASI

EXPERIMENTAL

* 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)

Interventions

Self- management for adequate sleep intervention (SASI) 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

SASI

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Susan Malone

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 26, 2018
• Study Start: November 1, 2018
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose

Locations

US (1)