TranQuill™ Sling Snoreplasty for Snoring and Mild Obstructive Sleep Apnea:

Completed · Not applicable

Conditions studied: Snoring, Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT02364518

Run by

Medical University of South Carolina

People needed

20

Starts

2014-02-01

Expected to finish

2014-08-01

Last updated by the study team

2018-09-10

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Department of Otolaryngology- Head and Neck Surgery- Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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