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

NCT02364518 | Completed

• 1 other identifier: TranQuill™ Sling Snoreplasty
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Snoring; Obstructive Sleep Apnea

Keywords

Snoring; snoreplasy; Tranquill; Sutures

Outcome Measures

Primary Outcomes (4)

• Apnea-Hypopnea Index

  0-100

  90 days

• Oxygen Desaturation Index

  0-100

  90 days

• Respiratory Disturbance Index

  0-100

  90 days

• Bed Partner Scoring

  0-10

  90 days

Study Arms (1)

Snoreplasty

EXPERIMENTAL

Treatment of Snoring and/or mild obstructive sleep apnea with snoreplasty.

Procedure: Snoreplasty

Interventions

Snoreplasty PROCEDURE

The procedure will be performed under local anesthesia in the examination chair. The subject's throat will be anesthetized with benzocaine spray followed by infiltration of the soft palate with 4-5 milliliters of 1% lidocaine with 1:100,000 epinephrine. The TranQuill suture will be inserted into the soft palate tissues using a predescribed pattern.

Snoreplasty

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Department of Otolaryngology- Head and Neck Surgery- Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Murphey AW, Nguyen SA, Fuller C, Weber AC, Camilon MP, Gillespie MB. TranQuill sling snoreplasty for snoring: A single-arm pilot study for safety and effectiveness. Laryngoscope. 2016 Jan;126(1):243-8. doi: 10.1002/lary.25361. Epub 2015 Nov 4.

  PMID: 26536156 DERIVED

MeSH Terms

Conditions

Snoring; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• M. Boyd Gillespie, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Shaun A Nguyen, MD, MA, CPI

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: February 18, 2015
• Study Start: February 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 10, 2018

Record last verified: 2018-09

Locations

US (1)