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Clinical Trials/NCT01946659
NCT01946659
Completed
Not Applicable

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

NYU Langone Health1 site in 1 country344 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
NYU Langone Health
Enrollment
344
Locations
1
Primary Endpoint
Change the knowledge of risk factors for sleep apnea and improve adherence to recommended assessment and treatment for sleep apnea.
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
December 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change the knowledge of risk factors for sleep apnea and improve adherence to recommended assessment and treatment for sleep apnea.

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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