Promoting Adherence to Sleep Apnea Treatment Among Blacks With Metabolic Syndrome

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT01946659
• Lead Sponsor: NYU Langone Health

Brief Summary

This is a randomized controlled Trial to evaluate effect of a culturally and linguistically tailored, telephone-delivered behavioral intervention on adherence to recommended assessment and treatment of sleep apnea in Blacks with Metabolic Syndrome. The investigators believe low awareness of Sleep Apnea and the risk it imposes to an individual health plays an important role in underdiagnosis and low adherence to treatment among Blacks. Hence, culturally and linguistically tailored health education will decrease the knowledge gap and improve adherence to recommended assessment and treatment of sleep Apnea. the investigators believe the effect of adherence to treatment of Sleep apnea is shown to improve the components of Metabolic syndrome and hence promote well control of Hypertension, Diabetes, weight, triglyceride and cholesterol.

Detailed Description

Primary aim: To evaluate effect of a culturally and linguistically tailored, telephone-delivered behavioral intervention, versus an attention-control condition, on adherence to recommended assessment and treatment of sleep apnea.

Secondary aims: 1) To evaluate the maintenance of intervention effects on adherence 6 months post-intervention; and 2) To assess treatment effects on components of the metabolic syndrome (waist circumference, blood pressure, lipid level, and fasting plasma glucose/HbA1C).

Exploratory aim: To identify the mediators of adherence to recommended sleep apnea assessment and treatment following exposure to the intervention.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-09
• Last Update Posted: 2015-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 344

Inclusion Criteria

• Age > 18 years
• African American / carribean American / African.

Exclusion Criteria

• Pregnancy or breastfeeding
• Involvement with other study
• Unable to understand and sign the informed consent form
• Heart attack or stroke within the past 12 weeks
• Diagnosed with Obstructive Sleep Apnea and/or on treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change the knowledge of risk factors for sleep apnea and improve adherence to recommended assessment and treatment for sleep apnea.	6 months	The knowledge of risk factors for sleep apnea will be measured by the Apnea knowledge/Apnea beliefs Scale. The adherence to recommended assessment and treatment for sleep apnea will be measured by Continuos Positive Airway Pressure machine.

Secondary Outcome Measures

Name	Time	Method
Change in the components of metabolic syndrome (as measured by Hba1c, triglycerides, and Blood pressure) for those who adhered to the treatment of Sleep Apnea	6 months	Components of Metabolic syndrome include Hypertension, Diabetes, weight, triglyceride and cholesterol.

Trial Locations

Locations (1)

New York University; 🇺🇸 New York, New York, United States