Tongue Exercises and Reflux Therapy for Upper Airway Resistance Syndrome

This study has been withdrawn prior to enrollment.
(Not enough subjects enrolled)
Sponsor:
Information provided by:
West Side ENT
ClinicalTrials.gov Identifier:
NCT00364481
First received: August 11, 2006
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Obstructive Sleep Apnea
Upper Airway Resistance Syndrome
Gastroesophageal Reflux
Drug: omeprazole
Behavioral: Tongue exercises
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Tongue Exercises and Laryngopharyngeal Reflux Therapy on Upper Airway Resistance Syndrome

Resource links provided by NLM:


Further study details as provided by West Side ENT:

Primary Outcome Measures:
  • 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.

Enrollment: 0
Study Start Date: August 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364481

Sponsors and Collaborators
West Side ENT
Investigators
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
  More Information

No publications provided

Responsible Party: Steven Park, West Side ENT
ClinicalTrials.gov Identifier: NCT00364481     History of Changes
Other Study ID Numbers: NYEE IRB 06.06
Study First Received: August 11, 2006
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by West Side ENT:
apnea
tongue
exercises
reflux
airway
upper
fatigue

Additional relevant MeSH terms:
Apnea
Gastroesophageal Reflux
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Regurgitation, Gastric
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014