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

NCT03599388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-05-15

No results posted yet for this study

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.

Conditions

  • Sleep
  • Metabolic Syndrome

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Susan Malone · NYU Langone Health

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-04-02
Completion
2019-04-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03599388 on ClinicalTrials.gov