Obstructive Sleep ApneaNCT00518128
Measuring Effectiveness in Sleep Apnea Surgery
A study testing Surgical OSA treatment and Positive Airway Pressure Therapy in people with Obstructive Sleep Apnea, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Surgical OSA treatment and Positive Airway Pressure Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jun 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unable to tolerate PAP, supported by statement from sleep physician
- Multilevel airway obstruction
- Elect to proceed with surgical OSA treatment (uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension)
- Tolerance of PAP during titration study and indication of willingness to use
- No previous treatment of PAP except during titration study
- Washout period of two weeks between PAP titration study and study assessment
- Matched to surgical group patient on age, gender, race, body mass index, and OSA disease severity (apnea-hypopnea index)
Who cannot join
- Pregnant women
- Primary snoring or mild OSA (apnea-hypopnea index < 15)
- Known neurologic, cardiac, hepatic, or renal disorder
- Acute illness or infection
- Co-existing sleep disorder other than primary snoring
- Unable to fast overnight prior to blood draw
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Department of Otolaryngology - Head and Neck Surgery
San Francisco, California, 94115
About this study
The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. To achieve this goal, we will examine key health-related (C-reactive protein, homocysteine, leptin, the homeostasis model of insulin resistance, and heart rate variability) and functional (sleep-related quality of life and vigilance) measures among a surgical group of OSA patients who do not tolerate non-surgical treatment (positive airway pressure, PAP) and a comparison group of matched OSA patients who tolerate PAP.
Read the detailed description
The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. To achieve this goal, we will examine key health-related (C-reactive protein, homocysteine, leptin, the homeostasis model of insulin resistance, and heart rate variability) and functional (sleep-related quality of life and vigilance) measures among a surgical group of OSA patients who do not tolerate non-surgical treatment (positive airway pressure, PAP) and a comparison group of matched OSA patients who tolerate PAP. We propose to measure the impact of surgical OSA treatment on these health-related and functional outcomes measures with the following three analyses: (1) to assess the changes seen with surgical treatment; (2) to compare changes seen with surgical and PAP treatment; and (3) to evaluate the association between changes in respiratory patterns during sleep and changes in health-related and functional outcomes measures for both surgical and PAP treatment.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Surgical OSA treatment, Positive Airway Pressure Therapy
- Keywords
- Obstructive Sleep Apnea, Leptin, Homocysteine, C-reactive protein
- 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.
Surgical OSA treatmentProcedure or surgery
Also called UPPP, GA hyoid myotomy and suspension
uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension
Positive Airway Pressure TherapyProcedure or surgery
Also called CPAP
Continuous positive airway pressure for treatment of obstructive sleep apnea
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Surgical OSA Treatment Group: Moderate to Severe OSA patients who are unable to tolerate PAP (Positive Airway Pressure) and elect to proceed with surgical treatment (surgical cohort). Receives: Procedure: Surgical OSA treatment |
| 2 | Active comparator | Positive Airway Pressure Therapy Comparison Group: Moderate to Severe OSA patients who tolerate PAP (Positive Airway Pressure). Receives: Procedure: Positive Airway Pressure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein level
Measured: Before and after surgery
Secondary outcomes (1)
Leptin, Homocysteine, Homeostasis model of insulin resistance (HOMA-IR), Heart rate variability, Functional Outcomes of Sleep Questionnaire and Psychomotor Vigilance Task.
Measured: Before and after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Eric Kezirian, University of California, San Francisco
- Investigators
- Eric Kezirian, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518128
- Sponsor's protocol ID
- RR024130
- Status last verified
- May 2012
- First submitted
- 16 Aug 2007
- Last updated
- 22 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kezirian EJ, Malhotra A, Goldberg AN, White DP. Changes in obstructive sleep apnea severity, biomarkers, and quality of life after multilevel surgery. Laryngoscope. 2010 Jul;120(7):1481-8. doi: 10.1002/lary.20946.
PubMed 20564750
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Effectiveness in Sleep Apnea Surgery
- ClinicalTrials.gov ID
- NCT00518128
- Acronym / sponsor ID
- RR024130
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Leptin, Homocysteine, C-reactive protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Aug 2007 (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.
The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. To achieve this goal, we will examine key health-related (C-reactive protein, homocysteine, leptin, the homeostasis model of insulin resistance, and heart rate variability) and functional (sleep-related quality of life and vigilance) measures among a surgical group of OSA patients who do not tolerate non-surgical treatment (positive airway pressure, PAP) and a comparison group of matched OSA patients who tolerate PAP.
Detailed description
The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. To achieve this goal, we will examine key health-related (C-reactive protein, homocysteine, leptin, the homeostasis model of insulin resistance, and heart rate variability) and functional (sleep-related quality of life and vigilance) measures among a surgical group of OSA patients who do not tolerate non-surgical treatment (positive airway pressure, PAP) and a comparison group of matched OSA patients who tolerate PAP. We propose to measure the impact of surgical OSA treatment on these health-related and functional outcomes measures with the following three analyses: (1) to assess the changes seen with surgical treatment; (2) to compare changes seen with surgical and PAP treatment; and (3) to evaluate the association between changes in respiratory patterns during sleep and changes in health-related and functional outcomes measures for both surgical and PAP treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Surgical OSA treatmentSurgical OSA Treatment Group: Moderate to Severe OSA patients who are unable to tolerate PAP (Positive Airway Pressure) and elect to proceed with surgical treatment (surgical cohort). |
| 2 | Active comparator | Procedure: Positive Airway Pressure TherapyPositive Airway Pressure Therapy Comparison Group: Moderate to Severe OSA patients who tolerate PAP (Positive Airway Pressure). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Unable to tolerate PAP, supported by statement from sleep physician
- Multilevel airway obstruction
- Elect to proceed with surgical OSA treatment (uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension)
- Tolerance of PAP during titration study and indication of willingness to use
- No previous treatment of PAP except during titration study
Key exclusion criteria (6 listed)
- Pregnant women
- Primary snoring or mild OSA (apnea-hypopnea index < 15)
- Known neurologic, cardiac, hepatic, or renal disorder
- Acute illness or infection
- Co-existing sleep disorder other than primary snoring
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 |
|---|---|---|
| Surgical OSA treatmentAlso: UPPP, GA hyoid myotomy and suspensionuvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension | Procedure or surgery | 1 |
| Positive Airway Pressure TherapyAlso: CPAPContinuous positive airway pressure for treatment of obstructive sleep apnea | Procedure or surgery | 2 |
Primary outcome
C-reactive protein level
Time frame: Before and after surgery
1 secondary outcome
Leptin, Homocysteine, Homeostasis model of insulin resistance (HOMA-IR), Heart rate variability, Functional Outcomes of Sleep Questionnaire and Psychomotor Vigilance Task.
Time frame: Before and after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2012.
- Derived from this study: PubMed 20564750Kezirian EJ, Malhotra A, Goldberg AN, White DP. Changes in obstructive sleep apnea severity, biomarkers, and quality of life after multilevel surgery. Laryngoscope. 2010 Jul;120(7):1481-8. doi: 10.1002/lary.20946.
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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.
Eric Kezirian, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical OSA treatment and Positive Airway Pressure Therapy in people with Obstructive Sleep Apnea, run by University of California, San Francisco at 1 site in United States.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 22 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
C-reactive protein level (time frame: Before and after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00518128, which also lists 1 linked publication.
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 22 May 2012.