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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this randomized, placebo-controlled, double-blind study will be to determine if postoperative steroids significantly improve subjects' pain compared to a placebo after undergoing sleep surgery. The secondary objective is to determine if this same course of steroids improves how quickly subjects can tolerate a regular diet after surgery. Further, another secondary objective is to see if this will decrease a patient's postoperative narcotic usage. Investigators also will assess sleepiness, nasal breathing, and eustachian tube dysfunction (ETD) after the procedure using the validated measures Preoperative Epworth Sleepiness Scale (ESS), Nasal Obstruction Symptom Evaluation Survey (NOSE), and Eustachian Tube Dysfunction Questionnaire (ETDQ-7) with an objective to see if these improve more or quicker in patients who receive postoperative steroids. Investigators hypothesize that postoperative steroids will significantly decrease a patient's pain quicker in their recovery, allow them to tolerate more oral intake early in their recovery, allow them to tolerate a regular diet earlier in their recovery, and reduce their postoperative narcotic usage. Investigators hypothesize that postoperative steroids will also improve patients' ESS, NOSE, and ETD scores postoperatively, but Investigators do not believe postoperative steroids will affect the oropharyngeal bleeding rate of patients. This study will provide pilot data to determine if postoperative steroids and what dosage should be part of a standardized postoperative regimen in patients undergoing sleep surgery.

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.

What data supports the effectiveness of the drug 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/hypopnoea index, which measures the severity of sleep apnea. This suggests that dexamethasone may help improve breathing patterns during sleep. ^{1 2 3 4 5}

How does the drug dexamethasone differ from other treatments for obstructive sleep apnea?

Dexamethasone is a corticosteroid that may help reduce inflammation in the airways, which is a different approach compared to common treatments like CPAP (continuous positive airway pressure) that physically keep the airways open. This anti-inflammatory action could be particularly beneficial for patients with OSA who have high levels of inflammatory markers. ^{1 3 5 6 7}

Research Team

Nicolas Poupore

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of fluticasone nasal spray for pediatric obstructive sleep apnea. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Intranasal corticosteroid therapy in the treatment of obstructive sleep apnea: A meta-analysis of randomized controlled trials. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Medical Therapy on Mild Obstructive Sleep Apnea in Adult Patients. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The effect of nasal tramazoline with dexamethasone in obstructive sleep apnoea patients. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Corticosteroids suppress in vitro tonsillar proliferation in children with obstructive sleep apnoea. [2015]

6. Japan pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea syndrome causes a pseudo-Cushing's state in Japanese obese patients with type 2 diabetes mellitus. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Intranasal budesonide treatment for children with mild obstructive sleep apnea syndrome. [2009]