Treatment for Obstructive Sleep Apnea

UC San Diego; Altman Clinical and Translational Research Institute Building, La Jolla, CA
Obstructive Sleep ApneaAcetazolamide - Drug
Eligibility
18 - 50
All Sexes

Study Summary

This trial will study if a mild diuretic drug, acetazolamide, can improve sleep apnea & cardiovascular health in young adults, offering an alternative treatment for millions of OSA patients who are unable to tolerate current treatments.

Eligible Conditions
  • Obstructive Sleep Apnea

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Hyperoxia
1
Acetazolamide
1
Mild Intermittent Hypoxia (MIH)

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: 14 days

14 days
24-hour Mean Blood Pressure
24-hour Mean Diastolic Blood Pressure
24-hour Mean Systolic Blood Pressure
Apnea
Epworth Sleepiness Scale (ESS)
Hypoxia
Heart rate
Overnight Memory Improvement (%)
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SDA) instrument
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment (SRI) instrument
Reactive Hyperemia Index
Response Speed
Short Form 36 (SF-36) Health Survey
Sleep Apnea Syndromes

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Hyperoxia
1
Acetazolamide
1
Mild Intermittent Hypoxia (MIH)

Trial Design

2 Treatment Groups

Acetazolamide, then Placebo, then optional open-label CPAP-therapy
1 of 2
Placebo, then Acetazolamide, then optional open-label CPAP-therapy
1 of 2

Experimental Treatment

46 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment · Has Placebo Group · Phase 2

Acetazolamide, then Placebo, then optional open-label CPAP-therapyExperimental Group · 3 Interventions: Acetazolamide, Placebo, Continuous Positive Airway Pressure · Intervention Types: Drug, Drug, Device
Placebo, then Acetazolamide, then optional open-label CPAP-therapyExperimental Group · 3 Interventions: Acetazolamide, Placebo, Continuous Positive Airway Pressure · Intervention Types: Drug, Drug, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetazolamide
2011
Completed Phase 4
~2910
Placebo
1995
Completed Phase 3
~2670
Continuous Positive Airway Pressure
2016
Completed Phase 3
~1290

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 14 days

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,051 Previous Clinical Trials
1,827,361 Total Patients Enrolled
Christopher Schmickl, MD, PhDPrincipal InvestigatorUniversity of California, San Diego
1 Previous Clinical Trials
20 Total Patients Enrolled

Eligibility Criteria

Age 18 - 50 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your body mass index (BMI) is 35 or lower.
References

Frequently Asked Questions

What criteria is necessary to qualify for this research program?

"Candidates satisfying the criteria of 18-50 years old and having been diagnosed with obstructive sleep apnea (OSA) may be approved for this study. The trial is presently enrolling around 46 participants." - Anonymous Online Contributor

Unverified Answer

Could this treatment prove detrimental to the wellbeing of participants?

"The safety of this therapeutic intervention has been evaluated and deemed a 2, as the trial is in Phase 2; which suggests that there are some data supporting its security but none demonstrating its utility." - Anonymous Online Contributor

Unverified Answer

What are the purposes of this investigation?

"Over a two-week period, the researchers aim to track and assess Apnea Hypopnea Index (AHI) as well as measure sleep disturbance using Patient-Reported Outcomes Measurement Information System's Sleep Disturbance Assessment scale with T-scores indicating levels of disruption. Additionally, they will evaluate Sleep Related Impairment (SRI) via PROMIS 8 item instrument also scored on T-scale for comparative analysis against baseline values in US general population. Lastly, Epworth Sleepiness Scale is used to gauge likelihood of dozing off in various scenarios ranging from 0 to 3 points per activity summed up for an overall" - Anonymous Online Contributor

Unverified Answer

Is this research enrolling senior citizens?

"This trial is limited to individuals aged 18-50 years old. On the other hand, 48 medical studies are available for minors and 237 research opportunities exist for those over 65." - Anonymous Online Contributor

Unverified Answer

Are there any opportunities to join this experiment?

"Per the information posted on clinicaltrials.gov, this investigation is no longer recruiting individuals as it was last updated on November 14th 2022. However, 293 other studies are currently searching for volunteers to partake in them." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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