RECRUITING

Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment

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

Central sleep apnea (CSA) is common in patients with heart failure and those using opioid analgesics. Unfortunately, effective treatment of central apnea remains elusive, pressure therapy given the modest efficiency of positive airway pressure therapy. The focus of this proposal is to identify mechanistic pathways to guide future therapeutic interventions for central sleep apnea based on the strong premise that multi-modality therapy will normalize respiration and hence mitigate adverse long-term consequences of CSA. The investigators' proposed studies will test combination therapies, including positive airway pressure (PAP) plus a pharmacological agent who have heart failure or are using opioid analgesics. The investigators anticipate that findings will inform future clinical trials to improve care and quality of life among Veterans suffering from central sleep apnea, which remains difficult to treat using existing approaches.

Official Title

Central Sleep Apnea: Physiologic Mechanisms to Inform Treatment

Quick Facts

Study Start:2021-01-07
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04118387

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:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women Veterans with central sleep apnea, defined as Apnea Hypopnea Index (AHI)\>15/hour with CAHI\>5/hour, will be included in the experiments
  1. * less than 18 years old
  2. * pregnant or breastfeeding female
  3. * have severe respiratory disease that require to be on oxygen
  4. * recent health event that may affect the ability to participate in the study,
  5. * Body Mass Index (BMI) is \>40 kg/m2
  6. * significant insomnia
  7. * mental instability
  8. * recent health event that may affect sleep
  9. * if at any time the principal investigator (PI) identifies that a certain drug is not suitable, or are unable to use the device that is used to treat sleep apnea, will be not be allowed to participate in the study

Contacts and Locations

Study Contact

M S Badr, MD
CONTACT
(313) 374-2038
sbadr@med.wayne.edu

Principal Investigator

M Safwan Badr, MD
PRINCIPAL_INVESTIGATOR
John D. Dingell VA Medical Center, Detroit, MI

Study Locations (Sites)

John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201-1916
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • M Safwan Badr, MD, PRINCIPAL_INVESTIGATOR, John D. Dingell VA Medical Center, Detroit, MI

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 Date2021-01-07
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-01-07
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Central sleep apnea
  • Polysomnography (PSG)
  • Respiratory arousal threshold
  • Apnea Hypopnea index
  • Central Apnea Hypopnea Index
  • Breathing instability
  • Apneic Threshold (AT)
  • Peripheral chemoreflex sensitivity
  • CO2 reserve
  • Plant gain
  • Controller gain

Additional Relevant MeSH Terms

  • Sleep Disordered Breathing
  • Able Bodied