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Neck Liposuction for the Treatment of Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT01117974
Recruitment Status : Withdrawn
First Posted : May 6, 2010
Last Update Posted : April 17, 2013
Sponsor:
Information provided by (Responsible Party):
Dennis West, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Procedure: liposuction of the neck Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neck Liposuction With Tumescent Anesthesia for the Treatment of Obstructive Sleep Apnea - A Pilot Study
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Liposuction 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).



Primary Outcome Measures :
  1. Apnea-hypopnea index [ Time Frame: Baseline (0 weeks) ]
  2. Change in the apnea-hypopnea index [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Sleep-related quality of life [ Time Frame: Baseline (Week 0) ]
  2. Change in sleep-related quality of life [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117974


Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Simon Yoo, MD Northwestern University
Principal Investigator: Dennis P West, PhD Northwestern University

Responsible Party: Dennis West, Associate Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01117974     History of Changes
Other Study ID Numbers: STU17637
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases