Obstructive Sleep ApneaNCT01117974
Neck Liposuction for the Treatment of Obstructive Sleep Apnea
A study testing liposuction of the neck in people with Obstructive Sleep Apnea, run by Northwestern University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- liposuction of the neck
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
About this study
Official title: 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- liposuction of the neck
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposuction of the neckProcedure or surgery
Liposuction will be performed to the surgical endpoint (skin thickness in the suctioned areas similar to that of surrounding non-treated skin).
| Study group | Role | What they receive |
|---|---|---|
| Liposuction | Experimental | Not described Receives: Procedure: liposuction of the neck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index
Measured: Baseline (0 weeks)
Change in the apnea-hypopnea index
Measured: 12 weeks
Secondary outcomes (2)
Sleep-related quality of life
Measured: Baseline (Week 0)
Change in sleep-related quality of life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis West, Northwestern University
- Investigators
- Simon Yoo, MD, Principal investigator, Northwestern UniversityDennis P West, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117974
- Sponsor's protocol ID
- STU17637
- Status last verified
- Apr 2013
- First submitted
- 19 Mar 2010
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neck Liposuction With Tumescent Anesthesia for the Treatment of Obstructive Sleep Apnea - A Pilot Study
- ClinicalTrials.gov ID
- NCT01117974
- Acronym / sponsor ID
- STU17637
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liposuction | Experimental | Procedure: liposuction of the neck |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liposuction of the neckLiposuction will be performed to the surgical endpoint (skin thickness in the suctioned areas similar to that of surrounding non-treated skin). | Procedure or surgery | Liposuction |
Primary outcome
Apnea-hypopnea index
Time frame: Baseline (0 weeks)
Change in the apnea-hypopnea index
Time frame: 12 weeks
2 secondary outcomes
Sleep-related quality of life
Time frame: Baseline (Week 0)
Change in sleep-related quality of life
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
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RecruitingObservational study
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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RecruitingPhase 1/2
DRonabinol Treatment of OSA
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Yoo, MD principal investigator
Northwestern University
Dennis P West, PhD principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A study testing liposuction of the neck in people with Obstructive Sleep Apnea, run by Northwestern University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea index (time frame: Baseline (0 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2013.