Tongue Exercises and Reflux Therapy for Upper Airway Resistance Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00364481
Recruitment Status : Withdrawn (Not enough subjects enrolled)
First Posted : August 15, 2006
Last Update Posted : December 20, 2012
Information provided by:
West Side ENT

Brief Summary:
Tongue exercises are described to improved snoring and acid reflux symptoms. Acid reflux treatment has been found to improve obstructive sleep apnea to a limited degree. Upper airway resistance syndrome is caused by resistance to breathing, leading to multiple respiratory event related arousals, leading to daytime fatigue and other various physical ailments. Tongue base or retrolingual collapse is implicated in upper airway resistance syndrome. We will measure sleep quality and quality of life indices before and after treatment for subjects that undergo tongue exercises only, acid reflux treatment only, and those that undergo both treatments.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Upper Airway Resistance Syndrome Gastroesophageal Reflux Drug: omeprazole Behavioral: Tongue exercises Phase 1

Detailed Description:
Upper airway resistance syndrome (UARS) is a distinct clinical disorder characterized by repetitive arousals during sleep due to soft tissue collapse of the pharynx. It is associated with chronic daytime fatigue, insomnia, cold extremities, low blood pressure, orthostatic intolerance, headaches/migraine/TMJ, and various gastrointestinal condition. Obstructive sleep apnea (OSA) is different in that once obstruction of the pharynx occurs, there are multiple periods of complete (apnea) or incomplete cessation of breathing (hypopnea). Untreated, it has been strongly associated with daytime sleepiness, hypertension, depression, coronary artery disease, stroke, and even death. One possible mechanism of pharyngeal obstruction is that the posterior tongue is susceptible to collapse when supine during sleep, which causes further collapse of the soft palate and related structures. Acid reflux is also known to frequently coexist with UARS and OSA, possibly by increasing upper airway edema and inflammation. Treating OSA has been shown to improve reflux symptoms, and vice versa. Tongue exercises are also found to improve snoring and reflux symptoms. This study aims to validate via pre and post treatment polysomnograms, the effectiveness of tongue exercises alone, acid reflux treatment alone, or a combination of both regimens. Twenty-five patients will be randomly assigned to each of the three groups. Measurements include the percent improvement of major sleep indices within each group, as well as between groups. Quality of life variables as well as acid reflux symptom scores will be addressed as well.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Tongue Exercises and Laryngopharyngeal Reflux Therapy on Upper Airway Resistance Syndrome
Study Start Date : August 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Omeprazole

Primary Outcome Measures :
  1. Sleep quality of life indices before and after treatment for all three groups, with measurement of improvement within each group, as well as between each groups.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • men and women ages 18 to 45
  • supine Park tongue position 3+ or greater
  • tonsil size 2 or less
  • Mueller's 2+ or less
  • Friedman Stage II/III
  • BMI ≤ 30
  • Symptoms of sleep apnea or UARS lasting for > 3 months: excessive daytime sleepiness, OR two of the following:

    • Choking or gasping during sleep
    • Recurrent awakenings from sleep
    • Unrefreshing sleep
    • Daytime fatigue
    • cold extremities
    • inability to sleep supine
    • irritable bowel syndrome / GERD / bloating
    • low blood pressure
    • orthostatic intolerance
  • AHI of < 5, and RDI > 10 (polysomnogram within 1 year of entry date)

Exclusion Criteria:

  • Significant nasal obstruction
  • Prior pharyngeal surgery
  • History of radiation to the head and neck
  • Dysmorphic facies or craniofacial syndrome
  • ASA class IV or V
  • Major depression or unstable psychiatric disorder
  • Contraindications to taking Omeprozole
  • Pregnancy
  • Illiteracy (unable to complete required forms)
  • No phone # or mailing address, or plans to change in 3 month period
  • Any further upper airway surgery within three month period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00364481

Sponsors and Collaborators
West Side ENT
Principal Investigator: Steven Y. Park, MD New York Eye & Ear Infirmary
Study Chair: Omar Burschtin, MD New York University
Study Chair: Janet M Bennett, M.Ed,CCC-SLP Asheville Speech Associates

Responsible Party: Steven Park, West Side ENT Identifier: NCT00364481     History of Changes
Other Study ID Numbers: NYEE IRB 06.06
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: December 20, 2012
Last Verified: December 2012

Keywords provided by West Side ENT:

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Gastroesophageal Reflux
Laryngopharyngeal Reflux
Pathologic Processes
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action