Back to resultsMinimally Invasive Tongue Suture For Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea, Upper Airway Resistance Syndrome
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tongue Sutures for Obstructive Sleep Apnea
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, upper airway resistance syndrome, tongue suture, retrolingual tongue collapse, minimally invasive
Eligibility Criteria
Inclusion Criteria:
Five patients will be recruited during a period of one year, or until a total of five patients have been recruited and have taken part. Patients must have undergone a formal overnight polysomnogram with documented obstructive sleep apnea within the past 2 years with no significant change in their weight or symptoms. They must have tried or refused all available nonsurgical options (CPAP or mandibular advancement devices), and must be ideal candidates for traditional upper airway surgery. Based on the polysomnogram results and specific entry criteria, patients will be recruited. All patients will undergo a full ENT examination and a fiberoptic laryngoscopy, examining the nasal cavity, palatal structures and tongue position, both in the sitting and supine positions (a routine part of the ENT examination).
Entry criteria include the following:
- men and women ages 18 to 65
- supine Park tongue position 3+ or greater
- tonsil size 2 or less
- Mueller's 2+ or less
- Friedman Stage II/III
- BMI ≤ 30
- AHI ≥ 5
Exclusion Criteria:
- Prior pharyngeal surgery
- History of radiation to the head and neck
- Dysmorphic facies or craniofacial syndrome
- ASA class IV or V
- Major depression or unstable psychiatric disorder
- Pregnancy
- Illiteracy (unable to complete required forms)
- No phone # or mailing address, or plans to change in 3 month period
- Any upper airway surgery within three month period
Sites / Locations
- 330 West 58th Street, Suite 610
- West Side ENT
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Pilot study of 5 patients, with an additional 20 patients with conditional approval by the IRB once the initial 5 patient's data is reviewed.
Outcomes
Primary Outcome Measures
Using standardized validated sleep disordered breathing and quality of life questionnaires (pre-op, 3 months, and 12 months). Patients will undergo a post-operative polysomnogram at 12 months.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00515580
Brief Title
Minimally Invasive Tongue Suture For Obstructive Sleep Apnea
Official Title
Minimally Invasive Genioglossus And Hyoid Advancement For Obstructive Sleep Apnea Using Silhouette Sutures: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Why Stopped
Results from first few subjects was not significantly improved over standard, traditional procedures.
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Side ENT
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pilot study to determine the usefulness of a newly developed, minimally invasive tongue suture procedure for people with obstructive sleep apnea.
Detailed Description
Obstructive sleep apnea is a common sleep-breathing disorder characterized by repetitive complete cessation of breathing due to pharyngeal obstruction. Untreated, it has been strongly associated with daytime sleepiness, hypertension, depression, coronary artery disease, stroke, and even death. It is estimated that up to 25% of men and 9% of women may suffer from this condition. One proposed mechanism of pharyngeal obstruction is that the posterior tongue is susceptible to collapse when supine during sleep, which causes further collapse of the soft palate and related structures. Treatment includes continuous positive airway pressure (CPAP), mandibular advancement devices, and various surgical options. There are many surgical options for treating tongue base collapse, many of which are morbid with significant pain and discomfort involved. Silhouette Sutures (Kolster Methods, Inc.) are designed to hold and grip soft tissues using intermittently placed dissolvable cones spaced by knots. It has been used widely for years for facial cosmetic procedures with excellent results and safety record. This is a pilot study evaluating the practicality and efficacy of using Silhouette Sutures in an innovative, minimally invasive technique that obviates the need for more aggressive and morbid procedures for obstructive sleep apnea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Upper Airway Resistance Syndrome
Keywords
obstructive sleep apnea, upper airway resistance syndrome, tongue suture, retrolingual tongue collapse, minimally invasive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Pilot study of 5 patients, with an additional 20 patients with conditional approval by the IRB once the initial 5 patient's data is reviewed.
Intervention Type
Procedure
Intervention Name(s)
Tongue Sutures for Obstructive Sleep Apnea
Other Intervention Name(s)
tongue suture, mandibular osteotomy and genioglossus advancement, hyoid myotomy and suspension, uvulopalatopharyngoplasty (UPPP), obstructive sleep apnea
Intervention Description
Mandibular osteotomy with placement of Silhouette sutures for genioglossus advancement and hyoid suspension.
Primary Outcome Measure Information:
Title
Using standardized validated sleep disordered breathing and quality of life questionnaires (pre-op, 3 months, and 12 months). Patients will undergo a post-operative polysomnogram at 12 months.
Time Frame
one year or until 5 patients enrolled and completed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Five patients will be recruited during a period of one year, or until a total of five patients have been recruited and have taken part. Patients must have undergone a formal overnight polysomnogram with documented obstructive sleep apnea within the past 2 years with no significant change in their weight or symptoms. They must have tried or refused all available nonsurgical options (CPAP or mandibular advancement devices), and must be ideal candidates for traditional upper airway surgery. Based on the polysomnogram results and specific entry criteria, patients will be recruited. All patients will undergo a full ENT examination and a fiberoptic laryngoscopy, examining the nasal cavity, palatal structures and tongue position, both in the sitting and supine positions (a routine part of the ENT examination).
Entry criteria include the following:
men and women ages 18 to 65
supine Park tongue position 3+ or greater
tonsil size 2 or less
Mueller's 2+ or less
Friedman Stage II/III
BMI ≤ 30
AHI ≥ 5
Exclusion Criteria:
Prior pharyngeal surgery
History of radiation to the head and neck
Dysmorphic facies or craniofacial syndrome
ASA class IV or V
Major depression or unstable psychiatric disorder
Pregnancy
Illiteracy (unable to complete required forms)
No phone # or mailing address, or plans to change in 3 month period
Any upper airway surgery within three month period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Y. Park, MD
Organizational Affiliation
West Side ENT, PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
330 West 58th Street, Suite 610
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
West Side ENT
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
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Minimally Invasive Tongue Suture For Obstructive Sleep Apnea
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