Minimally Invasive Tongue Suture For Obstructive Sleep Apnea

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.

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