Obstructive Sleep Apnea study: Acetazolamide vs Eszopiclone
Official title Endotypic Traits and Obstructive Sleep Apnea Surgery
ClinicalTrials.gov ID: NCT05953610
What this study is testing
What is Acetazolamide 500 MG QHS?
This is an investigational medicine being studied to see if it can help treat obstructive sleep apnea in people who cannot use other treatments. It is designed to change the body's acid balance to help stimulate breathing during sleep.
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 looks at factors that might influence how well people do after soft palate surgery and after taking medications that target other causes of sleep apnea.
- Who it's for
- Adults who have obstructive sleep apnea and are candidates for soft palate surgery.
- What's involved
- Participants may receive soft palate surgery and/or take acetazolamide or eszopiclone, and will have their sleep and related traits measured.
- Time commitment
- The study lasts for the period of surgery and medication treatment, with follow‑up visits to monitor outcomes.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- age ≥21 years;
- moderate to severe OSA (obstructive AHI ≥ 15 events/hour);
- central/mixed apnea index \<5 events/hour;
- intolerance of positive airway pressure (defined as use \< 2 hours/night at least 5 nights/week);
- intolerance or poor candidate for oral appliance;
You likely can't join if
- history of allergic reaction to either of the study drugs;
- people with prior serious allergic reaction (such as Stevens-Johnson syndrome) to sulfonamides;
- people with a history of hypersensitivity to either of the two study drugs;
- people who are on high-dose aspirin therapy due to risk of severe metabolic acidosis;
- people with severe kidney disease or severe liver disease;
- people with a history of electrolyte imbalance or adrenal insufficiency (due to risks related to acetazolamide);
See the full eligibility criteria
- age ≥21 years;
- moderate to severe OSA (obstructive AHI ≥ 15 events/hour);
- central/mixed apnea index \<5 events/hour;
- intolerance of positive airway pressure (defined as use \< 2 hours/night at least 5 nights/week);
- intolerance or poor candidate for oral appliance;
- participant has provided informed consent for palate surgery as part of their standard of care;
- tonsil size 0-2+ (without markedly enlarged tonsils that have high surgical success rates);
- DISE without evidence of complete tongue-related obstruction (reflecting poorer results with isolated palate surgery);
- medications stable for ≥2 months;
- body mass index \<35 kg/m2;
- absence of uncontrolled nasal obstruction;
- no prior pharyngeal surgery other than tonsillectomy;
- no neurologic, cardiac or pulmonary disorders;
- absence of psychiatric disorder except for treated depression or mild anxiety;
- no co-existing sleep disorder, such as narcolepsy, chronic insomnia, or restless legs syndrome;
- no use of hypnotics, anxiolytics, stimulants, or sedating antidepressants;
- no near-miss or prior motor vehicle crash due to sleepiness in past 12 months; and
- \<3 caffeinated beverages daily.
- history of allergic reaction to either of the study drugs;
- people with prior serious allergic reaction (such as Stevens-Johnson syndrome) to sulfonamides;
- people with a history of hypersensitivity to either of the two study drugs;
- people who are on high-dose aspirin therapy due to risk of severe metabolic acidosis;
- people with severe kidney disease or severe liver disease;
- people with a history of electrolyte imbalance or adrenal insufficiency (due to risks related to acetazolamide);
- people on ketoconazole or other strong CYP3A4 inhibitors (these will increase eszopiclone blood levels);
- pregnancy; and
- alcohol or substance abuse.
The study team makes the final eligibility decision.
Where it is enrolling
- Santa Monica, California, 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, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Santa Monica, California, 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.