NCT02628977

Brief Summary

The primary purpose of this study is to ascertain the effectiveness of tailored, peer based sleep health education and social support in increasing adherence rates to recommended Obstructive Sleep Apnea (OSA) evaluation and treatment among blacks at risk of Obstructive Sleep Apnea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,092

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

5.3 years

First QC Date

December 8, 2015

Last Update Submit

July 2, 2021

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure

    We will perform analysis on an intention-to-treat basis.

    12 Months

Secondary Outcomes (1)

  • Rate of Obstructive Sleep Apnea among black men and women at the community level

    12 Months

Study Arms (2)

OSA Health Education & Support Group

EXPERIMENTAL

Participants randomly assigned to the intervention arm will receive OSA health education and social support from a trained Peer educator.

Behavioral: Peer Based Sleep Health Education and Social Support

Attention Control Group

ACTIVE COMPARATOR

Participants in the attention control group will receive standard sleep literature, providing information about Obstructive Sleep Apnea and access to available sleep services.

Behavioral: Attention Control Group

Interventions

Peer Based Sleep Health Education and Social SupportBEHAVIORAL

Participants randomly assigned to the intervention arm will receive Obstructive Sleep Apnea education and social support from a trained Peer Educator.

OSA Health Education & Support Group
Attention Control GroupBEHAVIORAL

Participants assigned to this arm of the study will receive standard sleep literature, providing information about OSA and access to available sleep services.

Attention Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • self-reported race/ethnic minority
  • ages ≥18 years
  • accessible by telephone
  • consent to participate, which includes permission to release medical record information
  • A positive screening for OSA is necessary to be enrolled in the intervention protocol.

You may not qualify if:

  • are involved in another sleep study.
  • are unable to understand and sign this informed consent form.
  • know someone who is participating in this study.
  • had a heart attack or stroke within the past 12 weeks.
  • do not identify yourself as a racial/ethnic minority.
  • are pregnant.
  • Refuse to use the ARESTM home sleep test device.
  • Refuse to use the WatchPATTM home sleep test device.
  • are not at risk for sleep apnea.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Madison Ave

New York, New York, 10016, United States

Location

Related Publications (1)

  • Seixas AA, Trinh-Shevrin C, Ravenell J, Ogedegbe G, Zizi F, Jean-Louis G. Culturally tailored, peer-based sleep health education and social support to increase obstructive sleep apnea assessment and treatment adherence among a community sample of blacks: study protocol for a randomized controlled trial. Trials. 2018 Sep 24;19(1):519. doi: 10.1186/s13063-018-2835-9.

    PMID: 30249293DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Girardin Jean Louis, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2015

First Posted

December 11, 2015

Study Start

November 1, 2015

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

July 6, 2021

Record last verified: 2021-07

Locations

US(1)