Acetazolamide for Obstructive Sleep Apnea to Improve Heart Health

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Obstructive sleep apnea (OSA) is a severe type of snoring causing people to choke in their sleep. It affects millions of Americans, causing many health problems. For example, patients with OSA often feel very sleepy and are at risk of falling asleep while driving. OSA also causes elevated blood pressure increasing the risk for heart attacks and strokes. Patients with OSA are often treated with a face-mask that helps them breath at night but can be difficult to tolerate. In fact, about half the patients eventually stop using this mask. Because there are few other treatments (and no drug therapy), many OSA patients are still untreated. Of note, especially young adults (i.e. 18 to 50 years old) benefit from treating their OSA, but they are also less likely to use the mask. Acetazolamide (a mild diuretic drug) has been used for over 50 years to treat many different conditions and is well tolerated. Recent data suggest, that acetazolamide may help OSA patients to not choke in their sleep and lower their blood pressure. Especially young adults with OSA are likely to respond well to this drug. Further, its low cost (66¢/day) and once- daily dosing may be particularly attractive for young OSA patients unable or unwilling to wear a mask each night. But previous studies had many limitations and did not focus on young adults. The goal of this study is to test if acetazolamide can improve sleep apnea and cardiovascular health in young adults with OSA (18-50 years old), and how it does that. Thus, we will treat 46 young OSA patients with acetazolamide or placebo for 2 weeks each. The order in which participants receive the drug or placebo will be randomized. At the end of each 2 week period we will assess OSA severity and cardiovascular health. Thus, this study will help assess acetazolamide's potential value for OSA treatment, and may also help to identify patients who are most likely to respond to acetazolamide (including select individuals \>50 years of age). Ultimately, this work promises a drug therapy option for millions of OSA patients who are unable to tolerate current treatments.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Age 18 to 50 years

• Body mass index ≤ 35 kg/m2

• Untreated OSA (AHI ≥10/h)

• Abnormal blood pressure (\>120/80mmHg, or on stable anti-hypertensive therapy for \>1month)

Locations
United States
California
UC San Diego; Altman Clinical and Translational Research Institute Building
RECRUITING
La Jolla
Contact Information
Primary
Pamela DeYoung, RPSGT
sleepresearch@health.ucsd.edu
858 246 2183
Time Frame
Start Date: 2022-12-02
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 46
Treatments
Experimental: Acetazolamide, then Placebo, then optional open-label CPAP-therapy
Subjects will start with a 2-week ACETAZOLAMIDE regimen~* Day 1-13: Acetazolamide 500mg at bedtime at home~* Day 14: Acetazolamide 500mg at bedtime in the sleep laboratory~After a wash-out period, subjects will then cross-over to a 2-week PLACEBO regimen:~* Day 1-13: Placebo (matching Acetazolamide 500mg) at bedtime at home~* Day 14: Placebo (matching Acetazolamide 500mg) at bedtime in the sleep laboratory~After a wash-out period, subjects may then undergo an OPTIONAL, OPEN-LABEL 2-week CPAP regimen:~\- Day 1-14: CPAP will be used at home during sleep
Experimental: Placebo, then Acetazolamide, then optional open-label CPAP-therapy
Subjects will start with a 2-week PLACEBO regimen~* Day 1-13: Placebo (matching Acetazolamide 500mg) at bedtime at home~* Day 14: Placebo (matching Acetazolamide 500mg) at bedtime in the sleep laboratory~After a wash-out period, subjects will then cross-over to a 2-week ACETAZOLAMIDE regimen:~* Day 1-13: Acetazolamide 500mg at bedtime at home~* Day 14: Acetazolamide 500mg at bedtime in the sleep laboratory~After a wash-out period, subjects may then undergo an OPTIONAL, OPEN-LABEL 2-week CPAP regimen:~\- Day 1-14: CPAP will be used at home during sleep
Sponsors
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov