Tongue Exercises and Reflux Therapy for Upper Airway Resistance Syndrome

NCT00364481 | Withdrawn Phase 1

• 1 other identifier: NYEE IRB 06.06
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea; Upper Airway Resistance Syndrome; Gastroesophageal Reflux

Keywords

apnea; tongue; exercises; reflux; airway; upper; fatigue

Outcome Measures

Primary Outcomes (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.

Interventions

omeprazole DRUG

Tongue exercises BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Side ENT: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Gastroesophageal Reflux; Apnea; Motor Activity; Fatigue

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Steven Y. Park, MD

  New York Eye & Ear Infirmary

  PRINCIPAL INVESTIGATOR

• Omar Burschtin, MD

  New York University

  STUDY CHAIR

• Janet M Bennett, M.Ed,CCC-SLP

  Asheville Speech Associates

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: August 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: December 20, 2012

Record last verified: 2012-12