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New treatment option for Obstructive Sleep Apnea
Official title Endotypic Traits and Obstructive Sleep Apnea Surgery
ClinicalTrials.gov ID: NCT05953610
What this study is testing
What is Acetazolamide 500 MG QHS?
Acetazolamide 500 MG QHS is an investigational medicine, being studied as a potential treatment for obstructive sleep apnea.
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
- This study will examine factors associated with outcomes after soft palate surgery and medications (acetazolamide, eszopiclone) that may treat other potential causes of obstructive sleep apnea (loop gain, arousal threshold).
- 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
- are:
- 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);
You likely can't join if
- are:
- 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;
See the full eligibility criteria
- are:
- 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.
- are:
- 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's taking place
- Santa Monica, California, United States
- Westwood, Los Angeles, 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 - 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?
Study sites include Santa Monica, California, United States; Westwood, Los Angeles, California, 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.