Obstructive Sleep ApneaNCT00515580
Minimally Invasive Tongue Suture For Obstructive Sleep Apnea
A study testing Tongue Sutures for Obstructive Sleep Apnea in people with Obstructive Sleep Apnea and Upper Airway Resistance Syndrome, run by West Side ENT at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea, Upper Airway Resistance Syndrome
- What is being tested?
- Tongue Sutures for Obstructive Sleep Apnea
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2007to Aug 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Friedman Stage II/III
- BMI ≤ 30
- AHI ≥ 5
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
330 West 58th Street, Suite 610
New York, New York, 10019
West Side ENT
New York, New York, 10019
About this study
Official title: Minimally Invasive Genioglossus And Hyoid Advancement For Obstructive Sleep Apnea Using Silhouette Sutures: A Pilot Study
This is a pilot study to determine the usefulness of a newly developed, minimally invasive tongue suture procedure for people with obstructive sleep apnea.
Read the 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.
- Being tested
- Tongue Sutures for Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, upper airway resistance syndrome, tongue suture, retrolingual tongue collapse, minimally invasive
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue Sutures for Obstructive Sleep ApneaProcedure or surgery
Also called tongue suture, mandibular osteotomy and genioglossus advancement, hyoid myotomy and suspension, uvulopalatopharyngoplasty (UPPP)
Mandibular osteotomy with placement of Silhouette sutures for genioglossus advancement and hyoid suspension.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 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. Receives: Procedure: Tongue Sutures for Obstructive Sleep Apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year or until 5 patients enrolled and completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionAug 2008
- Study completionAug 2009
Why it stopped: Results from first few subjects was not significantly improved over standard, traditional procedures.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Side ENT
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Y. Park M.D., West Side ENT
- Investigators
- Steven Y. Park, MD, Principal investigator, West Side ENT, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515580
- Sponsor's protocol ID
- NYEEI IRB 07.20
- Status last verified
- Dec 2012
- First submitted
- 12 Aug 2007
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Genioglossus And Hyoid Advancement For Obstructive Sleep Apnea Using Silhouette Sutures: A Pilot Study
- ClinicalTrials.gov ID
- NCT00515580
- Acronym / sponsor ID
- NYEEI IRB 07.20
- Keywords
- obstructive sleep apnea, upper airway resistance syndrome, tongue suture, retrolingual tongue collapse, minimally invasive
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results from first few subjects was not significantly improved over standard, traditional procedures.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- West Side ENTUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 14 Aug 2007 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Tongue Sutures for Obstructive Sleep ApneaPilot study of 5 patients, with an additional 20 patients with conditional approval by the IRB once the initial 5 patient's data is reviewed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
- men and women ages 18 to 65
- supine Park tongue position 3+ or greater
- tonsil size 2 or less
- Mueller's 2+ or less
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Tongue Sutures for Obstructive Sleep ApneaAlso: tongue suture, mandibular osteotomy and genioglossus advancement, hyoid myotomy and suspension, uvulopalatopharyngoplasty (UPPP)Mandibular osteotomy with placement of Silhouette sutures for genioglossus advancement and hyoid suspension. | Procedure or surgery | A |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Results from first few subjects was not significantly improved over standard, traditional procedures.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
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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.
Steven Y. Park, MD principal investigator
West Side ENT, PLLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tongue Sutures for Obstructive Sleep Apnea in people with Obstructive Sleep Apnea and Upper Airway Resistance Syndrome, run by West Side ENT at 2 sites 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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Results from first few subjects was not significantly improved over standard, traditional procedures.). Results are not available in the source record.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2012.