RECRUITING

Rescue Pharmacotherapy for OSA

Talk to us

Conditions

Obstructive Sleep Apnea

Quick Navigation

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

Persistent obstructive sleep apnea (OSA) is common in people treated with mandibular advancement device (MAD) or hypoglossal nerve stimulation (HGNS). For most patients, these treatments are the last line of defense. If MAD or HGNS do not work, then patients are left to suffer the consequences of undertreated OSA. In this study, the investigators want to test the addition of a drug treatment to their regimen. Endotypes will be targeted pharmacologically with one of the following drugs: acetazolamide for a high loop gain, atomoxetine-plus-eszopiclone for poor pharyngeal muscle compensation, or trazodone for a low arousal threshold. This aim is expected to provide treatment strategies for rescuing non-responders to MAD or HGNS therapy.

Official Title

Treating Residual OSA With Endotype-directed Pharmacotherapy (Aim 3)

Quick Facts

Study Start:2023-07-01
Study Completion:2026-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05293600

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 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals who have failed MAD or HGNS therapy, defined as a residual AHI ≥ 15 events/hr on MAD or HGNS therapy.
  1. * Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:
  2. * Other sleep disorders: periodic limb movements (periodic limb movement index \> 20/hr), narcolepsy, or parasomnias.
  3. * Any unstable major medical condition.
  4. * Medications expected to stimulate or depress respiration (including opioids, barbiturates, benzodiazepines, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
  5. * Use of SSRIs/SNRIs.
  6. * Contraindications for atomoxetine, including:
  7. * pheochromocytoma
  8. * use of monoamine oxidase inhibitors
  9. * benign prostatic hypertrophy, urinary retention
  10. * untreated narrow angle glaucoma
  11. * bipolar disorder, mania, psychosis
  12. * clinically significant constipation, gastric retention
  13. * pre-existing seizure disorders
  14. * clinically-significant kidney disorders
  15. * clinically-significant liver disorders
  16. * clinically-significant cardiovascular conditions
  17. * severe hypertension (SBP\>180 mmHg or DBP\>110 mmHg measured at baseline)
  18. * cardiomyopathy (LVEF\<50%) or heart failure
  19. * advanced atherosclerosi
  20. * history of cerebrovascular events
  21. * history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation
  22. * other serious cardiac conditions that would raise the consequences of an increase in blood pressure or heart rate
  23. * myasthenia gravis
  24. * pregnancy/breast-feeding
  25. * Contraindications for eszopiclone, including:
  26. * Hypersensitivity to eszopiclone
  27. * Chronic Obstructive Pulmonary Disease (COPD)
  28. * Pregnancy
  29. * Breast feeding
  30. * Liver disease
  31. * Contraindications for acetazolamide, including:
  32. * Hyperchloremic acidosis
  33. * Hypokalemia
  34. * Hyponatremia
  35. * Adrenal insufficiency
  36. * Impaired kidney function
  37. * Hypersensitivity to acetazolamide or other sulfonamides.
  38. * Marked liver disease or impairment of liver function, including cirrhosis.
  39. * Contraindications for trazodone, including:
  40. * suicidal ideation
  41. * bipolar disorder, mania
  42. * use of monoamine oxidase inhibitors
  43. * coronary artery disease
  44. * cardiac arrhythmias
  45. * QT prolongation
  46. * hepatic disease
  47. * renal failure or impairment
  48. * closed angle glaucoma
  49. * priapism
  50. * pregnancy/breast-feeding

Contacts and Locations

Study Contact

David Andrew Wellman, MD
CONTACT
5089827401
awellman@bwh.harvard.edu

Study Locations (Sites)

Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

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 Date2023-07-01
Study Completion Date2026-10-30

Study Record Updates

Study Start Date2023-07-01
Study Completion Date2026-10-30

Terms related to this study

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea