Obstructive Sleep Apnea Clinical Trial
Official title:
TranQuill™ Sling Snoreplasty for Snoring and Mild Obstructive Sleep Apnea: A Single-arm, Pilot Study for Safety and Effectiveness
Verified date | September 2018 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the safety and effectiveness of TranQuillTM Sling (a
suture or thread used in surgery that is knotless) in snoreplasty (surgery procedure) for the
treatment of snoring and mild OSA in adult subjects. The TranQuill Sling Snoreplasty (QSS) is
a procedure where the suture will be inserted into the soft palate tissues for the treatment
of snoring and/or mild obstructive sleep apnea. Soft palate tissues are tissues in the back
of the roof of the mouth.
The research results will be used to provide data on feasibility (strengths and weaknesses),
safety, performance, and effectiveness data for the Surgical Specialties, Inc as a therapy
for snoring and/or mild obstructive sleep apnea. The TranQuillTM Sling is approved by the
U.S. Food and Drug Administration (FDA). The TranQuillTM Sling is used in all types of
surgery that involved deep tissues in the body.
The investigator in charge of the study is Dr. Boyd Gillespie. MUSC and Dr. Gillespie receive
financial support from Surgical Specialties, Inc. to conduct the study. MUSC is the only
place that this study will be conducted. For this research study the investigators plan to
enroll a total of up to 20 subjects at the Medical University of South Carolina.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years and older |
Eligibility |
Inclusion Criteria: - Age = 22 years (no upper limit) - Regular bed-partner - Chronic, disruptive snoring according to bed-partner - Snoring, upper airway resistance syndrome, or mild obstructive sleep apnea (AHI = 15; lowest O2 saturation = 85%) on home sleep testing with Watch-PAT - No prior surgical treatment for snoring or OSAS other than nasal surgery - Willing and capable of providing informed consent Exclusion Criteria: - Age < 22 years - No regular bed-partner - Intermittent or occasional snoring - Moderate-to-severe obstructive sleep apnea (AHI = 16; Lowest O2 sat <85%) or evidence of central apnea (= 10% of apneic events) on home sleep testing with Watch-PAT - BMI = 32 kg/m2 - Modified Mallampati 3 or 4 - Tonsil Grade 3 or 4 - Significant nasal obstruction (> 50% of nasal airway diameter on one side) - Previous palatal surgery (cleft palate; uvulopalatopharyngoplasty; uvulectomy; Pillar implants; Somnoplasty) - Current cigarette smoker (= 1 cigarette per day) - Known history of coronary artery disease or stroke - Chronic obstructive pulmonary disease (COPD) - Diabetes - Major depression or non-controlled psychiatric illness - Drug or alcohol abuse - Untreated or poorly controlled hypertension - Anticoagulation therapy (ex. Coumadin or Plavix; single baby aspirin per day allowable) - History of bleeding or clotting disorder - Another significant sleep disorder (e.g., insomnia, periodic limb movement) - Tonsillar hypertrophy - Chronic Obstructive Pulmonary Disease (COPD) - Interstitial Lung Disease (ILD) - Cystic Fibrosis - Acute Repiratory Distress Syndrome (ARDS) - Nasal or supraglottic obstruction on fiberoptic examination - ASA class III ,IV, V - Latex allergy - Lidocaine allergy - Pregnancy or plans to become pregnant Note: women of childbearing potential must demonstrate a negative pregnancy test upon enrollment and/or be using an acceptable form of birth control (OCPs; IUD). - Major depression or non-stabilized psychiatric disorder - Drug or alcohol abuse - Previous palatal or tongue surgery - Stable or unstable angina - CHF - Moderate or severe valvular disease - TIA/CVA - Carotid stenosis or endarterectomy - Anemia - Room air SpO2 < 95% - Pulmonary hypertension - Dialysis - Central or mixed apnea = 10% of respiratory events - Participation in another clinical study (enrolled in any concurrent study) whose investigational plan is judged to interfere or affect any of the measures of this study |
Country | Name | City | State |
---|---|---|---|
United States | Department of Otolaryngology- Head and Neck Surgery- Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Apnea-Hypopnea Index | 0-100 | 90 days | |
Primary | Oxygen Desaturation Index | 0-100 | 90 days | |
Primary | Respiratory Disturbance Index | 0-100 | 90 days | |
Primary | Bed Partner Scoring | 0-10 | 90 days |
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