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Clinical Trials/NCT02781701
NCT02781701WithdrawnNot Applicable

Tongue Protrusion Force: A Pilot Study

Weill Medical College of Cornell University1 site in 1 countryStarted: January 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
RDI

Study Overview

Brief Summary

From Weill Cornell Medical College Center for Sleep Medicine, the investigators will recruit patients (N = 25) with previously documented moderate to severe OSA. They will receive an all-night in-home sleep study to document the severity of their OSA immediately before starting the training regimen. Scales and questionnaires measuring sleepiness, snoring, fatigue, and insomnia will be administered prior to starting the training and repeated after six weeks of training. Subjects may be removed from the study due to failing to adhere to the training regimen at anytime via remote data monitoring. The principal measure of the efficacy of the treatment will be the change in RDI, the number of abnormal breathing events per hour of sleep.

Detailed Description

Obstructive sleep apnea (OSA) is a condition characterized by temporary diminutions or cessations of breathing caused by repetitive collapse of the upper airway (UA) during sleep (1). OSA is a common disorder associated with abnormalities in pharyngeal anatomy and physiology in which the muscles of the airway, which normally relax during sleep, fail to provide sufficient dilatory force to balance the contractive force from inspiratory activity (2). This force imbalance serves to either partially or completely collapse the UA, thereby preventing sufficient air from reaching the lungs. These pauses in breathing lead to blood oxygen desaturation and induce neurological arousal resulting in sleep disruption and fragmentation. The cycle of airway collapse and arousal can repeat hundreds of times per night (1). According to the National Sleep Foundation, OSA affects 18-22 million Americans, 80% of whom are undiagnosed. OSA is more prevalent among overweight and older individuals and those with reduced muscle tone, skeletal anomalies such as micrognathia or retrognathia, and airways crowded by redundant or enlarged soft tissue structures.

OSA is associated with significant physiological and psychological problems. OSA results in excessive daytime sleepiness, fatigue, memory impairment, and reduced reaction time, increasing the risk for motor vehicle (3) and workplace (4) accidents. In addition, OSA sufferers face increased cardiovascular risk including hypertension, heart disease, and stroke (5). OSA has even recently been linked to increased cancer incidence (6) and mortality (7), presumably through hypoxia-induced angiogenesis.

On the morning of December 1, 2013, a Metro-North passenger train derailed in the Bronx. The accident killed 4 passengers, injured 61, and caused $9 million worth of damage. Investigators determined human error was to blame: the train engineer admitted that before reaching the curve he had "gone into a daze," allowing the train to travel at three times the posted speed limit (8). A medical examination conducted after the accident diagnosed the train engineer with OSA, which hampered his ability to fully adjust his sleep patterns to the morning shift he had begun working just two weeks prior to the accident (9).

The Harvard Medical School released a report in 2010 entitled, "The Price of Fatigue: The Surprising Economic Costs of Unmanaged Sleep Apnea," in which it estimated the annual economic cost of moderate to severe OSA in the United States to be $65-165B (compared to $60B for drunk driving and $150B for not wearing seatbelts), including $10-40B in OSA-related traffic accidents and $5-20B in OSA-related workplace accidents (10).

Existing treatments for OSA include lifestyle modifications (11) such as weight loss, position restriction, and avoidance of muscle relaxants such as alcohol and benzodiazepine drugs. Oral appliances including mandibular advancement devices and tongue retaining devices have been increasingly employed. OSA is also treated through surgery, including tonsillectomy and uvulopalatopharyngeoplasty (UPPP) to reduce tissue crowding of the UA lumen, genioglossal advancement, and maxillomandibular advancement. The most widespread and generally effective treatment for OSA, however, remains the use of various devices for maintaining positive airway pressure (PAP) such as Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiPAP), and Autotitrating (AutoPAP) devices.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
21 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age: 21 to 70
  • At home confirmation of moderate to severe OSA (AHI 15-60)
  • BMI less than or equal to 35
  • Not currently on a weight loss plan and no intention of beginning a weight loss regimen during the duration of the study
  • If not currently treated for OSA (AHI 15-20), not planning on starting treatment for OSA during the duration of the study
  • Willing to have a diagnostic sleep study before the training
  • Willing to have a diagnostic sleep study after the training
  • Willing to perform tongue training exercises twice daily for 6 weeks
  • Willing to keep a sleep diary

Exclusion Criteria

  • Dental problems, e.g., less than a full complement of front teeth, loose front teeth, brittle teeth, by history
  • Temporomandibular joint (TMJ) disorder by history
  • Jaw, neck, or facial muscle pain or discomfort by history
  • Consumes more than one alcoholic beverage per day and unwilling to reduce alcohol consumption to no more than one alcoholic beverage per day (muscle relaxant)
  • On benzodiazepine medication (or specific muscle relaxant)
  • Sleeps less than 5 hours per night on average (sleep deprivation can weaken UA)
  • Has had an upper airway surgical procedure for sleep apnea below the level of the nasopharynx
  • Non-English speaker or illiterate

Outcomes

Primary Outcomes

RDI

Time Frame: Six weeks

RDI (the sum of apneas, hypopneas, and milder, more subtle sleep disruptions known as respiratory effort related arousals, or RERAs, that can still lead to sleep fragmentation).

Secondary Outcomes

  • dur50%(Six weeks)
  • AHI(Six Weeks)
  • TPFmax(Six Weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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