Clinical trial NCT01946659: Promoting Adherence to Sleep Apnea Treatment Among Blacks With Metabolic Syndrome
Official title: Promoting Adherence to Sleep Apnea Treatment Through Health Education Among Blacks With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Tailored Telephone Intervention
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: State University of New York - Downstate Medical Center
First posted: 2013-09-19
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Change the knowledge of risk factors for sleep apnea and improve adherence to recommended assessment and treatment for sleep apnea.
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
affiliation: NYU Langone Health
name: Girardin Jean-Louis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jean-Louis G, Newsome V, Williams NJ, Zizi F, Ravenell J, Ogedegbe G. Tailored Behavioral Intervention Among Blacks With Metabolic Syndrome and Sleep Apnea: Results of the MetSO Trial. Sleep. 2017 Jan 1;40(1):zsw008. doi: 10.1093/sleep/zsw008.
citation: Ramos AR, Wallace DM, Pandi-Perumal SR, Williams NJ, Castor C, Sevick MA, Mcfarlane SI, Jean-Louis G. Associations between sleep disturbances and diabetes mellitus among blacks with metabolic syndrome: Results from the Metabolic Syndrome Outcome Study (MetSO). Ann Med. 2015 May;47(3):233-7. doi: 10.3109/07853890.2015.1015601. Epub 2015 Apr 9.
citation: Williams NJ, Jean-Louis G, Brown CD, McFarlane SI, Boutin-Foster C, Ogedegbe G. Telephone-delivered behavioral intervention among blacks with sleep apnea and metabolic syndrome: study protocol for a randomized controlled trial. Trials. 2014 Jun 12;15:225. doi: 10.1186/1745-6215-15-225.