Clinical trial NCT01117974: Neck Liposuction for the Treatment of Obstructive Sleep Apnea
Official title: Neck Liposuction With Tumescent Anesthesia for the Treatment of Obstructive Sleep Apnea - A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2010-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Apnea-hypopnea index
timeFrame: Baseline (0 weeks)
measure: Change in the apnea-hypopnea index
timeFrame: 12 weeks
Secondary outcomes:
measure: Sleep-related quality of life
timeFrame: Baseline (Week 0)
measure: Change in sleep-related quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Simon Yoo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Dennis P West, PhD
role: PRINCIPAL_INVESTIGATOR
References: