ACTIVE_NOT_RECRUITING

Novel physIologiC prEdictors of Positive Airway Pressure Effectiveness

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

Millions of Americans suffer from high blood pressure, diabetes, strokes and motor vehicle accidents due to ineffective treatment of obstructive sleep apnea (OSA). Our preliminary data suggest that physiological causes of OSA such as easy arousability (low arousal threshold) or unstable breathing control (high loop gain) may influence effectiveness of OSA's most common treatment, continuous positive airway pressure (CPAP). The NICE-PAP study will examine how the physiologic traits that cause OSA in each individual impact CPAP effectiveness and can lead to personalized OSA treatments that improve patient lives.

Official Title

Novel physIologiC prEdictors of Positive Airway Pressure Effectiveness: NICEPAP Study Prospective Cohort

Quick Facts

Study Start:2022-01-01
Study Completion:2026-08-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05067088

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:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age of \>18 years
  2. 2. Newly diagnosed OSA naïve to CPAP
  3. 3. Apnea hypopnea index (AHI) ≥5/hr on in-laboratory polysomnography or home sleep test acquired and scored using standard criteria(59)
  4. 4. Referred for CPAP adherence management at Yale New Haven Hospital Sleep Center
  1. 1. Need for supplemental oxygen
  2. 2. Central apnea index comprising \>50% of the AHI
  3. 3. Treatment recommendation with another modality (e.g., Bilevel PAP, Adaptive Servo-Ventilation, Automatic Volume Pressure Assured Pressure Support)
  4. 4. A referral for a sleep disorder other than OSA (i.e., narcolepsy, sleep related movement disorder, circadian rhythm sleep-wake disorder)
  5. 5. Prior CPAP or Auto-CPAP use over the past 3 years
  6. 6. Unstable medical or mental health condition (e.g., decompensated heart failure, end-stage chronic obstructive pulmonary disease, end stage renal disease, psychosis)
  7. 7. Inability to participate in the informed consent process (e.g., cognitive impairment)
  8. 8. Pregnancy
  9. 9. Non-English language use as only means of communication (because the research budget does not provide adequate resources to ensure that the needs of non-English speaking patients can be adequately addressed)

Contacts and Locations

Principal Investigator

Andrey Zinchuk, MD, MHS
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale New Haven Hospital Sleep Center
North Haven, Connecticut, 06473
United States

Collaborators and Investigators

Sponsor: Yale University

  • Andrey Zinchuk, MD, MHS, PRINCIPAL_INVESTIGATOR, Yale University

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 Date2022-01-01
Study Completion Date2026-08-28

Study Record Updates

Study Start Date2022-01-01
Study Completion Date2026-08-28

Terms related to this study

Keywords Provided by Researchers

  • Continuous positive airway pressure (CPAP)
  • Physiologic sleep apnea traits (endotypes)
  • CPAP adherence
  • CPAP efficacy
  • Patient-centered sleep apnea outcomes
  • Precision medicine
  • Arousal threshold
  • Loop gain
  • Pharyngeal collapsibility
  • Pharyngeal muscle compensation

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea