Promoting Adherence to Sleep Apnea Treatment Among Blacks With Metabolic Syndrome

Obstructive Sleep Apnea Clinical Trial

— MetSO  

Official title:

Promoting Adherence to Sleep Apnea Treatment Through Health Education Among Blacks With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946659
• Other study ID #: 09-193
• Status: Completed
• Phase: N/A
• First received: February 5, 2013
• Last updated: September 9, 2015
• Start date: September 2009
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Apnea
• Metabolic Syndrome X
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Adherence to Sleep Apnea Treatment
A health education material prepared after focus group discussion with community leaders and patients would be administered to the participants with an experienced health educator through phone. Upto 10 calls per each patient will be made to either group until 6 months or the patient has a sleep test done.

Other:
• Standard Care Group
The standard care group gets a standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine

Locations

Country	Name	City	State
United States	New York University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change the knowledge of risk factors for sleep apnea and improve adherence to recommended assessment and treatment for sleep apnea.	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.	6 months	No
Secondary	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	Components of Metabolic syndrome include Hypertension, Diabetes, weight, triglyceride and cholesterol.	6 months	No