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Tongue Exercises and Reflux Therapy for Upper Airway Resistance Syndrome

Primary Purpose

Obstructive Sleep Apnea, Upper Airway Resistance Syndrome, Gastroesophageal Reflux

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
omeprazole
Tongue exercises
Sponsored by
West Side ENT
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring apnea, tongue, exercises, reflux, airway, upper, fatigue

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 11, 2006
    Last Updated
    December 18, 2012
    Sponsor
    West Side ENT
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00364481
    Brief Title
    Tongue Exercises and Reflux Therapy for Upper Airway Resistance Syndrome
    Official Title
    Effectiveness of Tongue Exercises and Laryngopharyngeal Reflux Therapy on Upper Airway Resistance Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Not enough subjects enrolled
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    August 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    West Side ENT

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea, Upper Airway Resistance Syndrome, Gastroesophageal Reflux
    Keywords
    apnea, tongue, exercises, reflux, airway, upper, fatigue

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    omeprazole
    Intervention Type
    Behavioral
    Intervention Name(s)
    Tongue exercises
    Primary Outcome Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Steven Y. Park, MD
    Organizational Affiliation
    New York Eye & Ear Infirmary
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Omar Burschtin, MD
    Organizational Affiliation
    New York University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Janet M Bennett, M.Ed,CCC-SLP
    Organizational Affiliation
    Asheville Speech Associates
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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