Dexamethasone for Obstructive Sleep Apnea

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Must not be taking: Steroids

Disqualifiers: Steroid allergies, Surgical complications, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if dexamethasone, a type of steroid, can enhance recovery after sleep surgery. Researchers seek to find out if it reduces pain and the need for painkillers, and if it helps patients resume normal eating sooner. They are also assessing improvements in sleepiness and nasal breathing. Individuals undergoing sleep surgery, such as tonsil removal, who can answer questions in English, may be suitable participants. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used steroids for more than three days in the 30 days before the surgery.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dexamethasone is generally safe for people. In past studies, it helped those with obstructive sleep apnea. One study found that it improved sleep quality without causing serious side effects. Another study reported a 21% reduction in apnea events (short pauses in breathing during sleep) when combined with another treatment. These findings suggest that dexamethasone is safe for use in medical settings. While no treatment is completely without risk, evidence indicates that dexamethasone is safe for sleep-related conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about using dexamethasone for obstructive sleep apnea because it offers a new approach compared to the usual treatments like CPAP machines or oral appliances. Dexamethasone, a steroid, could help reduce inflammation in the airways, which might improve breathing during sleep. This treatment is unique because it’s administered both intravenously and orally, potentially allowing for more flexibility and effectiveness. Unlike current options that often involve mechanical devices or surgeries, dexamethasone might provide a simpler, medication-based solution with quicker results.

What evidence suggests that dexamethasone might be an effective treatment for obstructive sleep apnea?

Research has shown that dexamethasone may reduce symptoms in people with obstructive sleep apnea (OSA). One study found that patients using dexamethasone with nasal tramazoline experienced 21% fewer apnea events, which are pauses in breathing during sleep. Another study reported a 50% reduction in the apnea-hypopnea index for some patients, indicating less severe sleep apnea. This trial will evaluate various administration methods of dexamethasone, including intravenous and oral doses, to determine its effectiveness in improving breathing during sleep for people with OSA. ^{2 3 6 7 8}

Who Is on the Research Team?

Nicolas Poupore

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals with Obstructive Sleep Apnea who have undergone sleep surgery. Participants should not have conditions that exclude them from the study, which are not specified in the provided information.

Inclusion Criteria

Ability to complete all study questions in English

I am scheduled for surgery to treat sleep disorders.

Exclusion Criteria

Any self-reported allergies to corticosteroids

Inability to perform study due to underlying medical condition

Inability to answer postoperative questionnaires due to underlying medical conditions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive postoperative steroids or placebo after sleep surgery

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for pain control, diet tolerance, and narcotic usage

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

Trial Overview

The study tests if taking 8mg of dexamethasone after sleep surgery reduces pain, speeds up return to a regular diet, and decreases narcotic use compared to a placebo. It's randomized and double-blind, meaning neither doctors nor patients know who gets the real drug or placebo.

How Is the Trial Designed?

Group I: 3 doses of intravenous placebo with 3 doses of oral 8mg dexamethasone Experimental Treatment 1 Intervention

Placebo administered intravenously, while the experimental drug is administered orally

Group II: 3 doses of intravenous 8mg dexamethasone with 3 doses of placebo Experimental Treatment 1 Intervention

Experimental drug administered intravenously, while the placebo is administered orally

Group III: 3 doses of intravenous 8mg dexamethasone with 3 doses of oral 8mg dexamethasone Experimental Treatment 1 Intervention

Experimental drug administered both intravenously and orally

Group IV: 3 doses of intravenous placebo with 3 doses of placebo Placebo Group 1 Intervention

Placebo administered both intravenously and orally

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

Intranasal corticosteroid therapy significantly reduces the apnea-hypopnea index in patients with obstructive sleep apnea (OSA) compared to placebo, based on a meta-analysis of five randomized controlled trials involving 221 participants.

Despite the positive findings, the evidence is limited by potential biases and variability among the studies, indicating a need for further research to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intranasal corticosteroid therapy in the treatment of obstructive sleep apnea: A meta-analysis of randomized controlled trials. Liu, HT., Lin, YC., Kuan, YC., et al.[2017]

Citations

1.

atsjournals.org

atsjournals.org/doi/abs/10.1164/ajrccm.2025.211.Abstracts.A4433

Dexamethasone as a Novel Treatment for Obstructive ...

Within the dexamethasone group, 2 participants experienced a clinically significant 50% decrease in OAHI. No significant differences between the groups were ...

2.

clinicaltrial.be

clinicaltrial.be/en/details/85474?only_active=0&only_eligible=0&only_recruiting=0&per_page=100

Dexamethasone Treatment for OSA in Children

The primary objective is to evaluate the efficacy of Dexamethasone in reducing the severity and symptoms of moderate to severe OSA in children ...

3.

withpower.com

withpower.com/trial/phase-2-sleep-apnea-obstructive-1-2025-06e9f

Dexamethasone for Obstructive Sleep Apnea

A study showed that using a combination of nasal tramazoline and dexamethasone in patients with obstructive sleep apnea led to a 21% decrease in the apnoea/ ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12474685/

Predicting treatment success in pediatric mild-to-moderate OSA

This study presents a validated nomogram model based on PSG and clinical parameters to predict treatment response to INCS in pediatric OSA, ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06818981

NCT06818981 | Post-Operative Steroids After Sleep Surgery

This study will provide pilot data to determine if postoperative steroids and what dosage should be part of a standardized postoperative regimen in patients ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6484579/

Effect of Dexamethasone on Nocturnal Oxygenation in ...

In addition, dexamethasone therapy prevented emergence of central sleep apnea and improved subjective sleep quality. Meaning. Patients with ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/23397296/

The effect of nasal tramazoline with dexamethasone in ...

Nasal tramazoline with dexamethasone in OSA patients with normal nasal resistance at wakefulness can restore the preponderance of nasal breathing epochs.

8.

trial.medpath.com

trial.medpath.com/clinical-trial/410d45aec0e1cc8a/dexamethasone-treatment-obstructive-sleep-apnea-children

Dexamethasone Treatment for OSA in Children - MedPath

This is a double-blinded clinical trial of children diagnosed with moderate to severe obstructive sleep apnea (OSA) on a baseline polysomnogram (PSG).