Extending Sleep to Reverse Metabolic Syndrome in Middle-aged Adults: Acceptability and Feasibility of a Sleep Intervention
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Endocrine |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 40 - 60 |
| Updated: | 1/13/2019 |
| Start Date: | November 1, 2018 |
| End Date: | March 31, 2019 |
| Contact: | Shannique K Richards |
| Email: | Shannique.Richards@nyumc.org |
| Phone: | 732-693-8081 |
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.
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.
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.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Susan Malone, MD
Phone: 646-501-2672
New York University School of Medicine NYU School of Medicine has a proud history that...
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