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

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ClinicalTrials.gov Identifier: NCT03599388
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : November 1, 2018
Actual Primary Completion Date : April 2, 2019
Actual Study Completion Date : April 2, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Measure of acceptability Pre-Intervention evaluated by the percentage of participants rating SASI as acceptable, neutral, unacceptable [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599388


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Susan Malone NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03599388    
Other Study ID Numbers: 18-00396
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

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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:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases