Clinical trial NCT00515580: 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
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Upper Airway Resistance Syndrome
Keywords: obstructive sleep apnea
upper airway resistance syndrome
tongue suture
retrolingual tongue collapse
minimally invasive
Lead sponsor: West Side ENT
Sponsor class: OTHER
First posted: 2007-08-14
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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.
timeFrame: one year or until 5 patients enrolled and completed
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: 330 West 58th Street, Suite 610
state: New York
city: New York
country: United States
facility: West Side ENT
state: New York
Study officials:
affiliation: West Side ENT, PLLC
name: Steven Y. Park, MD
role: PRINCIPAL_INVESTIGATOR
References: