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

September 6, 2018 updated by: Medical University of South Carolina

TranQuill™ Sling Snoreplasty for Snoring and Mild Obstructive Sleep Apnea: A Single-arm, Pilot Study for Safety and Effectiveness

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Methodology:

Subject Recruitment. Twenty subjects will be recruited from the MUSC Snoring Clinics as well as public information seminars held in the greater Charleston area. Attempts will be made to recruit both a gender and racially diverse study population.

Subject Screening. Subjects who are potentially eligible for the trial include patients who seek treatment chronic snoring disruptive to their bed-partner. Patients will require a pre-treatment assessment with a Watch-PAT home sleep study device to rule-out moderate and severe sleep apnea. Patients must have a regular bed-partner to participate in order to capture study outcomes.

Inclusion Criteria. Potential subjects must meet the following 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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Department of Otolaryngology- Head and Neck Surgery- Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Snoreplasty
Treatment of Snoring and/or mild obstructive sleep apnea with snoreplasty.
Procedure: Snoreplasty
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-Hypopnea Index
Time Frame: 90 days
0-100
90 days
Oxygen Desaturation Index
Time Frame: 90 days
0-100
90 days
Respiratory Disturbance Index
Time Frame: 90 days
0-100
90 days
Bed Partner Scoring
Time Frame: 90 days
0-10
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: M. Boyd Gillespie, MD, Medical University of South Carolina
  • Principal Investigator: Shaun A Nguyen, MD, MA, CPI, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

February 10, 2015

First Posted (Estimate)

February 18, 2015

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TranQuill™ Sling Snoreplasty

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Snoring

Clinical Trials on Snoreplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe