RECRUITING

Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study seeks to enhance long-term positive airway pressure (PAP) adherence among Spanish-speaking Hispanics, a group with known PAP outcomes disparities. This study will assess the feasibility of a linguistically and culturally adapted tele-management intervention (Automated Management, AM) for Spanish-speaking Hispanic adults with OSA.

Official Title

Enhancing Positive Positive Airway Pressure (PAP) Adherence Among Spanish-Speaking Hispanic Adults With Obstructive Sleep Apnea (OSA)

Quick Facts

Study Start:2023-10-15
Study Completion:2026-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05618444

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Spanish-speaking and reading
  2. * Self-identified Hispanic
  3. * Adults ≥ 18 years-old
  4. * Males and females
  5. * Moderate-severe OSA defined as AHI ≥15 events/hour using a hypopnea criterion of a 4% oxygen desaturation (AHI4%)
  6. * Expected availability for the duration of the study (6 months from date of randomization)
  7. * Ownership of smartphone with unlimited text messaging capability
  8. * Referred to PAP treatment and able and willing to be treated with PAP
  1. * Other sleep apnea or nocturnal respiratory insufficiency or failure diagnosis other than OSA established by polysomnogram (PSG) or home sleep apnea test (HSAT)
  2. * Requirement of supplemental oxygen or other non-invasive ventilation modality
  3. * Women referred to PAP because of new-onset OSA with pregnancy as PAP treatment may be time-limited (enrolled women who become pregnant during the trial and are already on PAP treatment will not be excluded)
  4. * Anticipated or scheduled bariatric surgery and/or referred to sleep evaluation by bariatric surgery

Contacts and Locations

Study Contact

Bruno Saconi, PhD
CONTACT
5702148191
bsaconi@geisinger.edu

Principal Investigator

Bruno Saconi, PhD
PRINCIPAL_INVESTIGATOR
Geisinger Clinic

Study Locations (Sites)

Kaiser Permanent Southern California
Fontana, California, 92335
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Geisinger
Danville, Pennsylvania, 17821
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Geisinger Clinic

  • Bruno Saconi, PhD, PRINCIPAL_INVESTIGATOR, Geisinger Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-15
Study Completion Date2026-05-30

Study Record Updates

Study Start Date2023-10-15
Study Completion Date2026-05-30

Terms related to this study

Keywords Provided by Researchers

  • positive airway pressure (PAP)
  • adherence
  • Hispanic
  • tele-management

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea