Status:
WITHDRAWN
Tongue Exercises and Reflux Therapy for Upper Airway Resistance Syndrome
Lead Sponsor:
West Side ENT
Conditions:
Obstructive Sleep Apnea
Upper Airway Resistance Syndrome
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 syndro...
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 dayt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00364481
Start Date
August 1 2006
End Date
August 1 2007
Last Update
December 20 2012
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