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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02507089
Other study ID # 13-01011
Secondary ID 1R25HL116378-01
Status Completed
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date February 1, 2018

Study information

Verified date June 2019
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to develop educational tools and platforms to promote the transfer of sleep health information to blacks to foster adoption of healthful sleep practices.


Recruitment information / eligibility

Status Completed
Enrollment 202
Est. completion date February 1, 2018
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- self-reported race/ethnicity as African American, African, Caribbean American or black men and women; ages =18 years;

- accessible by telephone; no plans to move away from the region within the year following enrollment;

- consent to participate, which includes permission to release medical record information;

- documented OSA risk based on scores received from the Apnea Risk Evaluation System questionnaire

Exclusion Criteria:

- progressive medical illness in which disability or death is expected within one year;

- impaired cognitive or functional ability which would preclude meaningful participation in the study;

- sleep apnea diagnosis;

- stated intention to move within the same year of enrollment.

Study Design


Intervention

Behavioral:
Tailored sleep health education materials.
Tailored sleep health materials.
Generic sleep health education materials.


Locations

Country Name City State
United States NYU Langone Medical Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
NYU Langone Health National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep Hygiene Index 6 months
Primary Apnea Knowledge/Apnea Belief Scale 6 months
Primary Self-Efficacy Scale 6 months
Primary Change Assessment Scale 6 months
Secondary 7-Day Physical Activity Recall 6 months
Secondary By-Meal Fruit/Vegetable Intake Screener 6 months
Secondary Rapid Estimate of Adult Literacy in Medicine 6 months
Secondary Medical Outcomes Study Short Form 36 6 months
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