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Neck Liposuction for the Treatment of Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

liposuction of the neck

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liposuction

Arm Description

Outcomes

Primary Outcome Measures

Apnea-hypopnea index

Change in the apnea-hypopnea index

Secondary Outcome Measures

Sleep-related quality of life

Change in sleep-related quality of life

Full Information

NCT ID

NCT01117974

First Posted

March 19, 2010

Last Updated

April 15, 2013

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT01117974

Brief Title

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

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Withdrawn

Study Start Date

undefined (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liposuction

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

liposuction of the neck

Intervention Description

Liposuction will be performed to the surgical endpoint (skin thickness in the suctioned areas similar to that of surrounding non-treated skin).

Primary Outcome Measure Information:

Title

Apnea-hypopnea index

Time Frame

Baseline (0 weeks)

Title

Change in the apnea-hypopnea index

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Sleep-related quality of life

Time Frame

Baseline (Week 0)

Title

Change in sleep-related quality of life

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simon Yoo, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dennis P West, PhD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Neck Liposuction for the Treatment of Obstructive Sleep Apnea

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