Sleep Disordered Breathing study: Zolpidem + PAP therapy vs Buspirone + PAP therapy
Official title Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment
ClinicalTrials.gov ID: NCT04118387
What this study is testing
What is Acetazolamide + supplemental oxygen + PAP therapy?
Acetazolamide + supplemental oxygen + PAP therapy is an investigational medicine, being studied as a potential treatment for sleep disordered breathing.
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
- The study aims to find out if using a breathing‑pressure device together with a medication can help people with central sleep apnea breathe better and reduce long‑term health problems.
- Who it's for
- It is looking for adults who have heart failure or are taking opioid pain medicines and have central sleep apnea.
- What's involved
- Participants will use a positive airway pressure machine and take a medication, and will have sleep studies and health check‑ups during the trial.
- Time commitment
- The study will last several months and requires regular clinic visits and sleep‑study appointments.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- less than 18 years old
- pregnant or breastfeeding female
- have severe respiratory disease that require to be on oxygen
- recent health event that may affect the ability to participate in the study,
- Body Mass Index (BMI) is \>40 kg/m2
- significant insomnia
See the full eligibility criteria
- 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
- less than 18 years old
- pregnant or breastfeeding female
- have severe respiratory disease that require to be on oxygen
- recent health event that may affect the ability to participate in the study,
- Body Mass Index (BMI) is \>40 kg/m2
- significant insomnia
- mental instability
- recent health event that may affect sleep
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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 and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Detroit, Michigan, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.