RECRUITING

Acetazolamide as a Means to Mitigate Falling Ventilatory Drive and Drive-dependent OSA

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Conditions

OSA

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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

Obstructive sleep apnea (OSA) is a highly prevalent disorder that has major consequences for cardiovascular health, neurocognitive function, risk of traffic accidents, daytime sleepiness, and quality of life. For years, a "classic" model of OSA has been used to describe the disorder, which fails to capture it's complexity. Recently, a model for OSA called drive-dependent OSA was discovered be more prevalent in the OSA population. This drive-dependent OSA is due to ventilation instability that occurs during respiratory events however these individuals have spontaneous increases in drive during respiratory events that stabilize their airway (i.e., via improving upper airway muscle activity) and reduce the risk of respiratory events in people with OSA. Therefore, by stabilizing the ventilatory drive, OSA should be treatable. Acetazolamide is a pharmacological ventilatory stimulant and has been previously shown to reduce OSA severity. As such in this study, the goal is to demonstrate acetazolamide improves OSA severity in 'drive-dependent' OSA people by improving drive-related pharyngeal obstructions compared to the 'classic' OSA people.

Official Title

Acetazolamide as a Means to Mitigate Falling Ventilatory Drive and Drive-dependent OSA

Quick Facts

Study Start:2024-01-31
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06091085

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:21 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 21-80 years
  2. * Suspected OSA (snoring, sleepiness, witnessed apneas, other clinical symptoms) or diagnosed OSA (severity not required)
  3. * Untreated; No use of OSA treatments within 2 weeks of the baseline study. No plans to start OSA treatments for the duration of the study protocol
  1. * Any unstable medical condition
  2. * Current use of the study medication.
  3. * Use of ventilatory stimulant or depressant medications that may complicated interpretation of results (including opioids, barbiturates, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
  4. * Contraindications for acetazolamide, including:
  5. * Allergies to sulfonamides - e.g. acetazolamide, hydrochlorothiazide, furosemide, sulfasalazine, celecoxib, sumatriptan, and zonisamide.
  6. * closed-angle glaucoma
  7. * adrenal insufficiency
  8. * known electrolyte or acid/base imbalance (hyponatremia, hypokalemia, hyperchloremia, metabolic acidosis, acidemia)
  9. * clinically-significant kidney disorders (eGFR\<60 ml/min/1.73m2)
  10. * clinically-significant liver disorders
  11. * Use of more than 500 mg/day of Aspirin, due to the potential for an interaction of acetazolamide and very high doses of Aspirin (acetylsalicylic acid, a salicylate drug)
  12. * Adrenocortical insufficiency
  13. * Low sodium or potassium
  14. * hyperchloremic acidosis
  15. * Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure, or any other unstable major medical condition.
  16. * Respiratory disorders other than obstructive sleep apnea:
  17. * central sleep apnea (\>75% of respiratory events scored as central)
  18. * chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions
  19. * Conditions likely to increase arousability from sleep: insomnia
  20. * Other sleep disorders that may complicate establishment of sleep: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias
  21. * For intramuscular electrodes and catheter: allergy to lidocaine
  22. * Highly-sensitive gag reflex. Patients with a self-reported 'highly-sensitive gag reflex', including an affirmative response to 'Do you sometimes gag when brushing your teeth?', will not take part in the physiology studies given the placement of an esophageal catheter
  23. * For intramuscular electrodes: use of aspirin or other oral anti-platelets / anti-coagulants
  24. * For oronasal mask: severe claustrophobia
  25. * Pregnancy or nursing

Contacts and Locations

Study Contact

Scott Sands, PhD
CONTACT
8579280341
sasands@bwh.harvard.edu
Atqiya Aishah, PhD
CONTACT
aaishah@bwh.harvard.edu

Principal Investigator

Dillon Gilbertson
STUDY_DIRECTOR
Brigham and Women's Hospital and Harvard Medical School
Scott Sands, PhD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital and Harvard Medical School

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02141
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Dillon Gilbertson, STUDY_DIRECTOR, Brigham and Women's Hospital and Harvard Medical School
  • Scott Sands, PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital and Harvard Medical School

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 Date2024-01-31
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-01-31
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • OSA