P20 Extending Sleep to Reverse Metabolic Syndrome in Middle-Aged Adults: Acceptability and Feasibility of a Sleep Intervention

• ClinicalTrials.gov Identifier: NCT03596983
• Recruitment Status: Completed
• First Posted: July 24, 2018
• Last Update Posted: June 11, 2021
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome	Behavioral: Sleep Intervention; Behavioral: Week 2 Intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: P20 Extending Sleep to Reverse Metabolic Syndrome in Middle-Aged Adults: Acceptability and Feasibility of a Sleep Intervention
• Actual Study Start Date: April 10, 2019
• Actual Primary Completion Date: June 4, 2021
• Actual Study Completion Date: June 4, 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: Short Sleep Patients

Behavioral: Sleep Intervention; Sleep Diaries (Daily); Fitbit 24/7; Phone/ video conference calls (weekly with study team); Epworth Sleepiness Scale (weekly); PROMIS fatigue scale-evening (weekly); Behavioral: Week 2 Intervention; Sleep Diaries (Daily); Phone Calls (weekly with study team); Wrist Accelerometry and fitbit 24/7 for 14 days; SAFTEE Questionnaire; ASA24; Behavioral risk factor surveillance system (smoking and alcohol use questions); Psychological well-being (SF36); Index of Self Regulation; PROMIS fatigue scale-morning (weekly); PROMIS fatigue scale-evening (weekly); Epworth Sleepiness Scale (weekly)

Outcome Measures

Primary Outcome Measures :

1. percentage of participants rating SASI [ Time Frame: 18 Weeks ]
   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).
2. Recruitment rate measured by the percentage of potential participants screened in order to enroll 30 participants [ Time Frame: 18 Weeks ]
3. Attrition rate measured by the percentage of enrolled participants completing the 15-week intervention [ Time Frame: 18 Weeks ]
4. Protocol adherence rates measured by the percentage of participants completing greater than or equal to 4 daily sleep diary entries per week for 80% or more of the intervention period. [ Time Frame: 18 Weeks ]

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New York

New York University

New York, New York, United States, 10010

Sponsors and Collaborators

NYU Langone Health

Investigators

• Principal Investigator: Susan Malone, MD; New York Langone Medical Center

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03596983
• Other Study ID Numbers: 18-00707
• First Posted: July 24, 2018
• Last Update Posted: June 11, 2021
• Last Verified: June 2021

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)
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NYU Langone Health:

sleep intervention; metabolic syndrome; hypertension; type 2 diabetes; abdominal obesity; dyslipidemia

Additional relevant MeSH terms:

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