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

Primary Purpose

Sleep, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self- management for adequate sleep intervention (SASI)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SASI

Arm Description

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)

Outcomes

Primary Outcome Measures

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
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).

Secondary Outcome Measures

Full Information

First Posted
July 13, 2018
Last Updated
May 14, 2020
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03599388
Brief Title
Extending Sleep to Reverse Metabolic Syndrome in Middle-aged Adults: Acceptability and Feasibility of a Sleep Intervention
Official Title
Extending Sleep to Reverse Metabolic Syndrome in Middle-aged Adults: Acceptability and Feasibility of a Sleep Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
April 2, 2019 (Actual)
Study Completion Date
April 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Metabolic Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SASI
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Self- management for adequate sleep intervention (SASI)
Intervention Description
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
Primary Outcome Measure Information:
Title
Measure of acceptability Pre-Intervention evaluated by the percentage of participants rating SASI as acceptable, neutral, unacceptable
Description
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
Time Frame
0 Months
Title
Measure of acceptability Post Intervention evaluated by the percentage of participants rating SASI as acceptable, neutral, unacceptable
Description
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).
Time Frame
4 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Malone
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose

Learn more about this trial

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

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