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Neck Liposuction for the Treatment of Obstructive Sleep Apnea

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Dennis West, Northwestern University
ClinicalTrials.gov Identifier:
NCT01117974
First received: March 19, 2010
Last updated: April 15, 2013
Last verified: April 2013
History of Changes

March 19, 2010
April 15, 2013
Not Provided
June 2012   (final data collection date for primary outcome measure)
  • Apnea-hypopnea index [ Time Frame: Baseline (0 weeks) ] [ Designated as safety issue: No ]
  • Change in the apnea-hypopnea index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01117974 on ClinicalTrials.gov Archive Site
  • Sleep-related quality of life [ Time Frame: Baseline (Week 0) ] [ Designated as safety issue: No ]
  • Change in sleep-related quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Sleep-related quality of life [ Time Frame: Baseline (Week 0) ] [ Designated as safety issue: No ]
  • Change in sleep-related quality of life [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
Neck Liposuction for the Treatment of Obstructive Sleep Apnea
Neck Liposuction With Tumescent Anesthesia for the Treatment of Obstructive Sleep Apnea - A Pilot Study

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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obstructive Sleep Apnea
Procedure: liposuction of the neck
Liposuction will be performed to the surgical endpoint (skin thickness in the suctioned areas similar to that of surrounding non-treated skin).
Experimental: Liposuction
Intervention: Procedure: liposuction of the neck
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01117974
STU17637
No
Dennis West, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Simon Yoo, MD Northwestern University
Principal Investigator: Dennis P West, PhD Northwestern University
Northwestern University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP