Clinical trial NCT03596983: P20 Extending Sleep to Reverse Metabolic Syndrome
Official title: P20 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: Metabolic Syndrome
Keywords: sleep intervention
metabolic syndrome
hypertension
type 2 diabetes
abdominal obesity
dyslipidemia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 44
Sex: ALL
Minimum age (years): 35
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 the acceptability and feasibility of a sleep extension intervention in community-dwelling, short-sleeping, racially/ethnically diverse middle-aged adults with MetS. Baseline sleep habits will be assessed and used to guide individualized strategies to extend sleep. A 1-group pretest-posttest 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 delivery, final follow up 3 weeks after last day of the 12-week intervention) on sleep duration, MetS risk behaviors (reduced physical activity, increased sedentary behavior, poor diet quality), symptoms associated with 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 approac

Detailed description: Screening and consent process. Potential participants will be informed about the study, provide verbal consent to be screened, and begin a multi-stage screening process consisting of a screening questionnaire (in person or by phone), an intake visit, and a home sleep test (OSA, sleep duration). The screening questionnaire will assess inclusion/exclusion criteria including demographics (NINR Demographic data), sleep duration and timing (STQ)70, insomnia symptoms (ISI), OSA symptoms (MAP), depressive symptoms (PROMIS depression v1.0), alcohol abuse (AUDIT), and self-reported habitual napping, sleep-promoting medication use, recent or planned shift work or trans-meridian travel, pregnancy/lactation, and current chemotherapy. Individuals meeting inclusion criteria based on the screening questionnaire will be invited to the CTSI visit. During the CTSI visit, the study team will describe the study and obtain written informed consent. MetS diagnosis will be confirmed based on measures of waist circumference, fasting glucose, serum triglycerides, high density lipoprotein cholesterol (HDL-c), and resting blood pressure. Waist circumference will assessed as the mean of 3 measurements taken at the level of the umbilicus using non-distensible measuring tape. Blood pressure will be assessed as the average of 3 recordings each taken 1 minute apart, following 10 minutes of inactivity. A 4th recording will occur if any two systolic or diastolic readings are \>5 mmHg apart. Fasting glucose, serum triglycerides, and HDL-c will be measured from blood samples drawn according to standard venipuncture protocol at the CTSI. Analysis will be completed at the CTSI lab using standard techniques for analyzing the blood samples. Retained participants will be trained to use a home sleep apnea testing device (Embletta MPR) to objectively screen for OSA, a wrist accelerometer, and a sleep diary to screen for short sleep. Written instructions and study team contact information will be provided. Participants will return the home sleep apnea testing device in a prepaid package. Data will be downloaded from the home sleep apnea testing device and scored by a sleep technician to confirm the absence of moderate/severe OSA (AHI ≥15).

Baseline data collection. Retained participants will complete the remaining baseline measures for sleep duration, MetS risk behaviors (physical activity, sedentary behavior, diet quality, smoking, and alcohol use), sleep deprivation symptoms (quality of life/affective well-being, fatigue) and self-regulation. After baseline week 2, the study team will contact participants to remind them to return the accelerometer in the prepaid shipping package. Participants meeting all the inclusion criteria will be invited to participate in the intervention.

Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 35 years of age and less than or equal to 60 years of age. Middle aged adults have the highest prevalence of short sleep compared to other stages of adulthood.
* Objectively confirmed MetS defined by three or more of the following: a) waist circumference greater than 120cm (men) or 88cm (women), b) blood pressure greater than or equal to 135 mmHg systolic or greater than or equal to 85 mmHg diastolic or antihypertensive medication use, c) fasting glucose greater than or equal to 110 mg/dL or insulin or oral hypoglycemic medication use, d) serum triglycerides greater than or equal to 150mg/dL or hypertriglyceride medication use, e) 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 conditions.
* Accelerometry confirmed short sleep (average work day sleep less than or equal to 6.5 hours/night). Self-reported sleep may overestimate sleep duration. This will ensure that participants will have short sleep patterns that are associated with MetS outcomes.
* English speaking. Participants will need to demonstrate adequate English comprehension (assessed during informed consent).

Exclusion Criteria:

* Pregnancy/lactation (self-reported). Pregnancy and lactation can disrupt habitual sleep patterns, and hormonal changes during pregnancy increase insulin resistance and may confound MetS.
* Current chemotherapy treatments (self-reported). Current chemotherapy treatments may contribute to fatigue and sleep disturbances.
* Alcohol abuse/dependence will be assessed with the Alcohol Use Disorders Identification Test (a measure that has demonstrated good reliability and validity). Alcohol abuse/dependence may contribute to sleep disturbances and limit the participant's ability to take part in sleep interventions.
* Night shift or shift work (previous 2 months), trans-meridian travel (previous 4 weeks), or planned shift work or trans-meridian travel during intervention period (self-reported). These will be to ensure that sleep estimates from baseline represent participants' habitual sleep and to ensure adherence with the sleep intervention.
* Moderate-severe or severe depression will be assessed with the PHQ-9. Moderate-severe depression or severe depression may contribute to sleep disturbances and interfere with the participant's ability to adhere to the sleep interventions.
* Chronic use of sleep-promoting medications (self-reported). These may interfere with sleep patterns and limit the participant's ability to take part in the sleep interventions.
* Habitual napping, defined as 2 naps per day or \> 90 minutes of napping on 3 or more days of the week will be assessed during baseline with accelerometry. This will be to ensure adherence with the sleep intervention.
* Diagnosed but untreated obstructive sleep apnea.

Primary outcomes:
measure: SASI Acceptability Questionnaire Score at Pre-Intervention
timeFrame: Baseline
measure: SASI Acceptability Questionnaire Score at Post-Intervention
timeFrame: Week 15
measure: Recruitment Rate
timeFrame: Baseline
measure: Retention Rate
timeFrame: Up to Week 15
measure: Protocol Adherence Rate
timeFrame: Week 15
Secondary outcomes:
measure: Change in Sleep Duration
timeFrame: Baseline, Week 15
measure: Change in SAFTEE Questionnaire Scores
timeFrame: Baseline, Week 15
measure: Change in Physical Activity
timeFrame: Baseline, Week 15
measure: Change in Index of Self-Regulation (Sleep) Score
timeFrame: Baseline, Week 15
measure: Change in PROMIS Fatigue 6a Morning Score
timeFrame: Baseline, Week 15
measure: Change in PROMIS Fatigue 6a Evening Score
timeFrame: Baseline, Week 15
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Susan Malone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wright F, Malone SK, Wong A, D'Eramo Melkus G, Dickson VV. Addressing Challenges in Recruiting Diverse Populations for Research: Practical Experience From a P20 Center. Nurs Res. 2022 May-Jun 01;71(3):218-226. doi: 10.1097/NNR.0000000000000577. Epub 2022 Jan 24.