Propofol sedation for Obstructive Sleep Apnea

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Obstructive Sleep ApneaPropofol sedation - Drug
Eligibility
3 - 11
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effects of two anesthetics on upper airway collapse during sleep endoscopy in children with sleep apnea.

Eligible Conditions
  • Obstructive Sleep Apnea

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: During Drug Induced Sleep Endoscopy (DISE) procedure, as judged subsequently by video review by the three raters

During Drug Induced Sleep Endoscopy (DISE) procedure, as judged subsequently by video review by the three raters
Mean obstruction score at the tongue base

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Dexmedetomidine sedation
1 of 2
Propofol sedation
1 of 2

Experimental Treatment

90 Total Participants · 2 Treatment Groups

Primary Treatment: Propofol sedation · No Placebo Group · Phase 2

Dexmedetomidine sedation
Drug
Experimental Group · 1 Intervention: Dexmedetomidine sedation · Intervention Types: Drug
Propofol sedation
Drug
Experimental Group · 1 Intervention: Propofol sedation · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine sedation
2015
Completed Phase 3
~110

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: during drug induced sleep endoscopy (dise) procedure, as judged subsequently by video review by the three raters

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,588 Previous Clinical Trials
46,945,909 Total Patients Enrolled
Erin KirkhamLead Sponsor

Eligibility Criteria

Age 3 - 11 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have severe preoperative OSA.
Parent/guardian ability to understand and willingness to sign a written informed consent..
You have symptoms of sleep apnea, but you have small tonsils.
Parent/guardian must understand/read/speak English or Spanish and be able and willing to complete questionnaires.