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NCT Number: NCT01946659

Promoting Adherence to Sleep Apnea Treatment Among Blacks With Metabolic Syndrome

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adherence to Sleep Apnea Treatment

Behavioral

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 names: Linguistically and culturally tailored intervention

Standard Care Group

Other

The standard care group gets a standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine

Primary outcomes

  1. 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

  1. 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

    Time frame: 6 months

    Components of Metabolic syndrome include Hypertension, Diabetes, weight, triglyceride and cholesterol.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • State University of New York - Downstate Medical Center

Registry information

Official study title

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

Acronym: MetSO

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2013
Registry last updated
Sep 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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