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Completed

NCT Number: NCT03219034

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Mental Disorders Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas A&M University College of Dentistry

Dallas, Texas, 75246, United States

About this study

The two prominent oral appliances used in treating obstructive sleep apnea differ in their designs, mid-line traction versus bilateral thrust. From a clinical perspective, it is important to know which design is superior and should be the 'treatment of choice' for improving airway function and sleep quality. These two designs differ in their protrusive mechanisms that are categorized in general under four main types: bilateral compression, bilateral thrust, midline compression and mid-line traction. Although the two designs considered in this proposal have undergone the most rigorous testing individually, well controlled 'head-to-head' trials as proposed here have not been conducted to determine their efficacy within a single test population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral appliance - A ; washout; oral appliance B

Device

Anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. 1 week washout followed by anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.

Other names: "TAP1" Oral Appliance; washout; "SomnoDent Flex"

oral appliance - B; washout; oral appliance A

Device

Anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. 1-week washout followed by anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible.

Other names: "SomnoDent Flex"; washout; "TAP1"

Primary outcomes

  1. Respiratory Event Index (REI) at T2

    Time frame: 4 weeks

    Number of apneas and hypopneas (respiratory events) per hour of recording; REI was reported instead of AHI, as it is a more appropriate measure for home sleep testing.

Secondary outcomes

  1. Stable Sleep Percent

    Time frame: 4 weeks

    Percent of stable sleep during the recording, specifically the percentage of high frequency coupling (HFC%) from cardiopulmonary coupling (CPC) Analysis

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

Mid-line Traction Versus Bilateral Thrust Oral Appliances: A Trial to Determine Superiority for Improving Upper Airway Function and Sleep Quality

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 17, 2017
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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