Title

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

    Phase 1
  • Study Type

    Interventional
  • Status

    Withdrawn
  • Intervention/Treatment

    omeprazole ...
  • Study Participants

    0
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.
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 Started
Aug 31
2006
Primary Completion
Aug 31
2007
Study Completion
Aug 31
2007
Last Update
Dec 20
2012
Estimate

Drug omeprazole

Behavioral Tongue exercises

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
No Results Posted