Recruiting PHASE1, PHASE2 Sleep Apnea

New treatment option for Sleep Apnea

Official title Sleep Disordered Breathing With Opioid Use

ClinicalTrials.gov ID: NCT05589753

What this study is testing

What is Acetazolamide?

Acetazolamide is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for sleep apnea.

Also referred to as ACZ.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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).
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 89. Healthy volunteers may be eligible.

You may be able to join if

  • Veterans, age 18-89 years
  • Veterans with prescription opioids

You likely can't join if

  • Patients with BMI\>40kg/m2 will be excluded to avoid the effects of morbid obesity on pulmonary mechanics and ventilatory control
  • Patients with history of unresolved/untreated cardiac disease, including recent myocardial infarction, recent bypass surgery, untreated atrial and...
  • Congestive heart failure with Cheyne-Stokes respiration (CSR)
  • Current unstable angina
  • Recent stroke
  • Untreated schizophrenia
See the full eligibility criteria
Who can join
  • Veterans, age 18-89 years
  • Veterans with prescription opioids
What rules you out
  • Patients with BMI\>40kg/m2 will be excluded to avoid the effects of morbid obesity on pulmonary mechanics and ventilatory control
  • Patients with history of unresolved/untreated cardiac disease, including recent myocardial infarction, recent bypass surgery, untreated atrial and ventricular tachy-bradycardias
  • Congestive heart failure with Cheyne-Stokes respiration (CSR)
  • Current unstable angina
  • Recent stroke
  • Untreated schizophrenia
  • Untreated hypothyroidism
  • Unresolved seizure disorder
  • Severe respiratory, neurological, liver and renal diseases
  • Unstable psychiatric disorders/untreated PTSD
  • Traumatic brain injury
  • Pregnant women
  • Significant sleep disorder such as narcolepsy, parasomnias disorder
  • Failure to give informed consent
  • Patients on tramadol and suboxone/buprenorphine

The study team makes the final eligibility decision.

Where it's taking place

  • Detroit, Michigan, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 89 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.