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N/A N=62 Randomized Treatment

Trial on Oral Appliance Design for Improving Upper Airway Function and Sleep Quality

Obstructive Sleep Apnea

Bottom Line

View on ClinicalTrials.gov: NCT03219034 ↗
Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Respiratory Event Index (REI) at T2 — 12.8; 21.1; 9.3; 13.1 number of events per hour — p=0.152

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
oral appliance - A ; washout; oral appliance B (Device); oral appliance - B; washout; oral appliance A (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Texas A&M University
Primary completion
Mar 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Respiratory Event Index (REI) at T2		 12.8; 21.1; 9.3; 13.1 0.152
SECONDARY
Stable Sleep Percent		 49.35; 48.7; 47.82; 52.38 —

Summary

This study will compare the effectiveness of the two leading oral appliances (OAs) designs for the treatment of severe obstructive sleep apnea in overweight adults. The effectiveness of OAs has come under question since different designs are combined in evaluating treatment efficacy, for example when comparing them to continuous positive airway pressure Due to the wide range of reported efficacy (53 to 90%), it is of great value to identify the most effective design to guide sleep practitioners and patients.

Eligibility Criteria

Inclusion Criteria

  • OSA PSG or PG diagnosed adults within 1 year
  • age >18
  • Currently treated with continuous positive airway pressure (CPAP)
  • AHI ≥ >30 events/hour of sleep
  • Two or more OSA symptoms (snoring, witnessed apnea or daytime hypersomnolence complaint)
  • BMI ≥ 30
  • At least 8 teeth per arch to support either OA device
  • Central and mixed apnea index <5 events/hour
  • Mallampati score from I to III
  • Palatine tonsils - grade 0, 1, or 2
  • Consent to study's timeline
  • Willingness to wear home sleep test apparatus for at least 4 nights
  • Willingness to wear an oral appliance every night for 8 weeks
  • Willingness to pick up and return home sleep test kits as needed

Exclusion Criteria

  • Cardiac & pulmonary disease (e.g., congestive heart failure, severe arrhythmias, COPD);
  • Central sleep apnea;
  • Comorbidities with other sleep disorders
  • No active TMD or jaw muscle pain
  • Morphological airway abnormalities
  • Pre-existing difficulty swallowing; throat or neck related health issues
  • Endocrine dysfunction
  • Severe psychiatric disorders;
  • Previous OA therapy; ENT surgery
  • Restrictions in jaw opening
  • Pregnancy / breast feeding or intent to become pregnant during the study
  • Inability to apply the sleep recorders
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03219034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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