Clinical trial NCT03599388: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Metabolic Syndrome
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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:

  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.

Primary outcomes:
measure: Measure of acceptability Pre-Intervention evaluated by the percentage of participants rating SASI as acceptable, neutral, unacceptable
timeFrame: 0 Months
measure: Measure of acceptability Post Intervention evaluated by the percentage of participants rating SASI as acceptable, neutral, unacceptable
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Susan Malone
role: PRINCIPAL_INVESTIGATOR
References: