RECRUITING

Sleep Disordered Breathing With Opioid Use

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

There is an increased risk for sleep disordered breathing (SDB), sleep-related hypoventilation and irregular breathing in individuals on chronic prescription opioid medications. Almost 30% of a veteran sleep clinic population had opioid-associated central sleep apnea (CSA). The proposal aims to identity whether oxygen and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in chronic opioid use via different mechanisms. We will study additional clinical parameters like quality of life, sleep and pain in patients with and without opioid use. This proposal will enhance the investigators' understanding of the pathways that contribute to the development of sleep apnea with opioid use. The investigators expect that the results obtained from this study will positively impact the health of Veterans by identifying new treatment modalities for sleep apnea.

Official Title

Targeting Chemoreceptor Control of Breathing During Sleep to Mitigate Opioid-Associated Sleep Disordered Breathing

Quick Facts

Study Start:2019-05-02
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05589753

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 to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veterans, age 18-89 years
  2. * Veterans with prescription opioids
  1. * Patients with BMI\>40kg/m2 will be excluded to avoid the effects of morbid obesity on pulmonary mechanics and ventilatory control
  2. * Patients with history of unresolved/untreated cardiac disease, including recent myocardial infarction, recent bypass surgery, untreated atrial and ventricular tachy-bradycardias
  3. * Congestive heart failure with Cheyne-Stokes respiration (CSR)
  4. * Current unstable angina
  5. * Recent stroke
  6. * Untreated schizophrenia
  7. * Untreated hypothyroidism
  8. * Unresolved seizure disorder
  9. * Severe respiratory, neurological, liver and renal diseases
  10. * Unstable psychiatric disorders/untreated PTSD
  11. * Traumatic brain injury
  12. * Pregnant women
  13. * Significant sleep disorder such as narcolepsy, parasomnias disorder
  14. * Failure to give informed consent
  15. * Patients on tramadol and suboxone/buprenorphine

Contacts and Locations

Study Contact

Ruchi Rastogi, MS
CONTACT
(313) 576-4464
ruchi.rastogi@va.gov

Principal Investigator

Susmita Chowdhuri, MD MS
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

  • Susmita Chowdhuri, MD MS, 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 Date2019-05-02
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-05-02
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Sleep Apnea
  • Opioid Use
  • Sleep Disordered Breathing