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Promoting Adherence to Sleep Apnea Treatment Among Blacks With Metabolic Syndrome (MetSO)

NYU Langone Health logo

NYU Langone Health

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Behavioral: Adherence to Sleep Apnea Treatment
Other: Standard Care Group

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

344 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

344 participants in 2 patient groups

Adherence to Sleep Apnea Treatment
Experimental group
Description:
The intervention arm of the study receives tailored education regarding Sleep Apnea by the study health educator via telephone.
Treatment:
Behavioral: Adherence to Sleep Apnea Treatment
Standard Care Group
Other group
Description:
The standard care group gets the standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine.
Treatment:
Other: Standard Care Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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