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NCT06818981 · ClinicalTrials.gov registry record · Phase 2
Post-Operative Steroids After Sleep Surgery
A Phase 2 study of Obstructive Sleep Apnea, sponsored by Medical University of South Carolina.
- Active
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT06818981: Active Phase 2 study of Obstructive Sleep Apnea, sponsored by Medical University of South Carolina.
NCT06818981 is a Phase 2 study of Obstructive Sleep Apnea that is active but no longer recruiting, run by Medical University of South Carolina. The registered enrollment target is 120 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06818981, a Phase 2 study of Obstructive Sleep Apnea, is active but no longer recruiting, sponsored by Medical University of South Carolina.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
As determined by a validated visual analog scale, with scores being scaled from 0 to 10, with 0 being the lowest score (no pain) and 10 being the highest score (most extreme amount of pain)
Conditions Studied
Interventions
- DRUG 8mg dexamethasone
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-02-01 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 2 |
What the registry record for NCT06818981 still lists
NCT06818981 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which 8mg dexamethasone is the first listed.
NCT06818981 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT06818981 about?
NCT06818981 is a clinical study titled "Post-Operative Steroids After Sleep Surgery". 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 ...
What is the current status of trial NCT06818981?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2025-02-01. Estimated completion is 2028-06-30.
What conditions does trial NCT06818981 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT06818981?
The interventions under investigation include: 8mg dexamethasone (DRUG).
Who is sponsoring clinical trial NCT06818981?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06818981 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06818981's enrollment target sits among peer trials
120 61st of 155 higher than 92 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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