Tongue Exercises and Reflux Therapy for Upper Airway Resistance Syndrome

Effectiveness of Tongue Exercises and Laryngopharyngeal Reflux Therapy on Upper Airway Resistance Syndrome

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.

Study Overview

• Status: Withdrawn
• Conditions: Obstructive Sleep Apnea; Gastroesophageal Reflux; Upper Airway Resistance Syndrome
• Intervention / Treatment: Drug: omeprazole; Behavioral: Tongue exercises

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
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: August 11, 2006
• First Submitted That Met QC Criteria: August 11, 2006
• First Posted (Estimate): August 15, 2006

Study Record Updates

• Last Update Posted (Estimate): December 20, 2012
• Last Update Submitted That Met QC Criteria: December 18, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: fatigue; reflux; apnea; airway; tongue; exercises; upper
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Gastrointestinal Diseases; Sleep Apnea Syndromes; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Sleep Apnea, Obstructive; Syndrome; Gastroesophageal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole
• Other Study ID Numbers: NYEE IRB 06.06