SnoringNCT02364518
TranQuill™ Sling Snoreplasty for Snoring and Mild Obstructive Sleep Apnea:
A study testing Snoreplasty in people with Snoring and Obstructive Sleep Apnea, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Snoring, Obstructive Sleep Apnea
- What is being tested?
- Snoreplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 43Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Otolaryngology- Head and Neck Surgery- Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
Read the 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
- Conditions
- Snoring, Obstructive Sleep Apnea
- Being tested
- Snoreplasty
- Keywords
- Snoring, snoreplasy, Tranquill, Sutures
- Medical subject headings
- Snoring, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SnoreplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Snoreplasty | Experimental | Treatment of Snoring and/or mild obstructive sleep apnea with snoreplasty. Receives: Procedure: Snoreplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index
0-100
Measured: 90 days
Oxygen Desaturation Index
0-100
Measured: 90 days
Respiratory Disturbance Index
0-100
Measured: 90 days
Bed Partner Scoring
0-10
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SnoringStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M. Boyd Gillespie, MD, Principal investigator, Medical University of South CarolinaShaun A Nguyen, MD, MA, CPI, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364518
- Sponsor's protocol ID
- TranQuill™ Sling Snoreplasty
- Status last verified
- Sep 2018
- First submitted
- 15 Apr 2014
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26536156
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TranQuill™ Sling Snoreplasty for Snoring and Mild Obstructive Sleep Apnea: A Single-arm, Pilot Study for Safety and Effectiveness
- ClinicalTrials.gov ID
- NCT02364518
- Acronym / sponsor ID
- TranQuill™ Sling Snoreplasty
- Conditions
- Snoring, Obstructive Sleep Apnea
- Keywords
- Snoring, snoreplasy, Tranquill, Sutures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Snoreplasty | Experimental | Procedure: SnoreplastyTreatment of Snoring and/or mild obstructive sleep apnea with snoreplasty. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (43 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SnoreplastyThe 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. | Procedure or surgery | Snoreplasty |
Primary outcome
Apnea-Hypopnea Index
Time frame: 90 days
0-100
Oxygen Desaturation Index
Time frame: 90 days
0-100
Respiratory Disturbance Index
Time frame: 90 days
0-100
Bed Partner Scoring
Time frame: 90 days
0-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Derived from this study: PubMed 26536156Murphey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Boyd Gillespie, MD principal investigator
Medical University of South Carolina
Shaun A Nguyen, MD, MA, CPI principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snoreplasty in people with Snoring and Obstructive Sleep Apnea, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (time frame: 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02364518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.