Neck Liposuction for the Treatment of Obstructive Sleep Apnea

Northwestern University

Status

Withdrawn

Conditions

Obstructive Sleep Apnea

Treatments

Procedure: liposuction of the neck

Study type

Interventional

Funder types

Other

Identifiers

NCT01117974

STU17637

Details and patient eligibility

About

Liposuction, one of the most common cosmetic procedures performed in the United States, is a surgical technique used to reduce localized areas of excess subcutaneous fat. The neck is a common area of treatment, where liposuction reduces fat volume and neck size. We hypothesize that suctioned removal of fat of the neck will reduce the severity of obstructive sleep apnea.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18-60 years of age
Subjects must have documented mild to moderate obstructive sleep apnea(OSA) syndrome within the last year from the Northwestern University Sleep Clinic
Subjects must qualify as "very sleepy" on the Epworth Sleepiness Scale
Females must have neck circumference of 16.0 cm or greater, and males must have neck circumference of 17.0 cm or greater
Subjects must be a good candidates for neck liposuction as determined by the study physician
Subjects must be in good health and is able to undergo the liposuction procedure

Exclusion criteria

Pregnant or lactating female
Subjects who are unable to understand the protocol or to give informed consent
Subjects dependent on blood thinners
Subjects with bleeding diathesis
Subjects with a history of poor wound healing, skin fragility, poor skin elasticity, or hypertrophic or keloidal scarring
Subjects with a history of excessive surgeries on the neck in the area to be treated
Subjects who are allergic to lidocaine or who have previously had an adverse reaction to epinephrine
Subjects with non-apnea sleep disorders such as restless leg syndrome, insomnia, circadian rhythm disorders
Subjects with chronic obstructive pulmonary disease
Subjects with craniofacial abnormalities
Subjects with hypoventilation
Subjects with large tonsils/adenoids or an abnormal airway exam as determined by the study physician
Subjects with an anatomical nasal obstruction
Subjects who have a large tongue
Subjects with severe cardiopulmonary risks as determined by the study physician
Subjects who cannot complete an MRI
Subjects who intend to pursue other treatments for OSA during the duration of this study
Any previous and/or pending procedures at the treatment area or that may likely affect the treatment area
Pending and/or anticipated major change in diet or exercise pattern in the six weeks following the last treatment
Subjects with a Body Mass Index >35kg/m2
Subjects treated with continuous positive airway pressure (CPAP) within one month of study enrollment