Sleep Apnea, ObstructiveNCT01539278
Effect of Adenotonsillectomy on Quality of Life in Children With Mild Obstructive Sleep Apnea
A study testing Adenotonsillectomy in people with Sleep Apnea, Obstructive, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
In children, enlarged adenoids and/or tonsils are the most common cause of obstructive sleep apnea (OSA), which is temporary blockage of breathing during sleep. Surgery to remove the tonsils and adenoids is the first-line treatment for disorder, and has been shown to cure the majority of children. Read more about this study
- Who is it for?
- Ages 3 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Adenotonsillectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Oct 2013
- 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 3 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any obstructive breathing symptoms such as snoring, mouth-breathing, sleep pauses, gasping, restless sleep, witnessed apneas, daytime somnolence, and enuresis.
- Children between the ages of 3-16 years of age that have had a sleep study with an Apnea Hypopnea Index (AHI) score of 1 to 5.
Who cannot join
- Subject/LAR unwillingness to comply with all study procedures
- Prior otolaryngologic surgery
- Prior sleep study
- Pregnant or breastfeeding
- Under 3 years of age and older than 16 years of age
- Congenital head and neck malformations or other syndromes
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
About this study
In children, enlarged adenoids and/or tonsils are the most common cause of obstructive sleep apnea (OSA), which is temporary blockage of breathing during sleep. Surgery to remove the tonsils and adenoids is the first-line treatment for disorder, and has been shown to cure the majority of children. However, for children with only a mild degree of OSA and few symptoms, surgery is less clear-cut, since two-thirds of these children do not develop worsening disease.
Research shows that some children with mild OSA and behavior problems are helped by removing the tonsils and adenoids. In children with all degrees of OSA, surgery has improved scores on tests that measure quality of life (QOL).
The investigators hypothesize that children with mild OSA will demonstrate changes on QOL assessment following adenotonsillectomy. These findings may help to guide the surgeon in selecting the children with mild OSA who are more likely to benefit from surgery.
Read the detailed description
Obstructive sleep apnea (OSA) is a sleep-related breathing disorder that is characterized by intermittent episodes of upper airway collapse and cessation of airflow during sleep. It comprises the severest extent of a spectrum of sleep disordered breathing (SDB) which includes primary snoring and upper airway resistance syndrome. OSA is a cause cardiovascular morbidity in adults and children and a public health concern, affecting 2-4% of the middle aged population (Giles 2009) and 2-3% of children in the United States (Katz 2010). It is further associated with an increased mortality risk in adults (Giles 2009) and well-described metabolic, cardiovascular, and neuropsychological deficits in children (Katz 2010). The latter symptoms include changes in behavior, memory and cognition, and poor school performance.
In children, adenotonsillar hyperplasia is uniformly the most common cause of upper airway obstruction, and the first-line therapy for these children is adenotonsillectomy (Darrow 2007). While its effectiveness is complicated by children with obesity and other comorbidities, the most recent analyses of outcomes using postsurgical apnea-hypopnea index reveal that adenotonsillectomy alone is able to cure approximately 60% of child OSA (Friedman 2010). Improvements have also been shown with neuropsychological outcomes such as behavior, school performance, attention, and others. (Katz 2010).
"Mild OSA" is an evolving definition; it is characterized by the polysomnographic finding of AHI range greater than 1 and less than 5, defined by Katz and Marcus.(Wagner 2007) This range corresponds to the difference in the defined pathological minimum AHI for children (normal AHI < 1) and adults (normal AHI < 5). In practice, "mild OSA" remains a common reason for delaying adenotonsillectomy in an otherwise asymptomatic child, since children with mild OSA have been shown to exhibit neurocognitive functioning equivalent to controls.(Calhoun 2009) However, psychosocially these children often have problems, and adenotonsillectomy has been shown to improve these children's behavior as measured by atypicality, depression, hyperactivity, and somatization.(Mitchell 2007) Furthermore, among one-third of children with mild OSA, the natural history is progression of disease.(Li 2010)
Psychosocial problems also become manifest using health-related quality-of-life (QOL) symptom scores. The study of QOL in children with OSA has become an area of scholarly interest in the last 15 years. It was only in 2000 that an OSA-specific QOL questionnaire was first developed and validated for use in children (2000 Franco). A recent meta-analysis of QOL following adenotonsillectomy revealed significant improvements in QOL scores in patients undergoing surgery for all severity levels of OSA.(2008 Baldassari) This meta-analysis included studies using validated QOL instruments, namely the Child Health Questionnaire (CHQ) and OSA-18.
Only one study of QOL in children with mild OSA found no clinically significant differences between patients who underwent adenotonsillectomy and controls; however, disease-specific QOL instrument (such as the OSA-18) was not used.(van Staaij 2004)
The investigators hypothesize that children with mild OSA will demonstrate changes on QOL assessment following adenotonsillectomy, particularly in OSA-specific domains. If true, a threshold for preoperative QOL scores may serve as a relative indication for adenotonsillectomy in the setting of mild OSA, independent of behavioral issues.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Adenotonsillectomy, Observation alone / no intervention
- Keywords
- Sleep Apnea, Obstructive, Child, Tonsillectomy, Adenoidectomy
- 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.
AdenotonsillectomyProcedure or surgery
Also called T&A
Tonsils and adenoids are surgically removed
Observation alone / no interventionOther
Patients are observed over time, no surgery is done, subjects complete QOL questionnaires at set intervals
| Study group | Role | What they receive |
|---|---|---|
| Observation, no surgery (control) | Active comparator | Patients have been diagnosed with mild OSA, no intervention is done; enrolled patients may be randomly or nonrandomly placed in this group Receives: Other: Observation alone / no intervention |
| Surgery (adenotonsillectomy) | Experimental | Patients who have been diagnosed with mild OSA. Patient may be randomly assigned or non-randomly choose to be in this group; all undergo adenotonsillectomy Receives: Procedure: Adenotonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health-related Quality of Life (HR-QOL) from baseline, as measured by the OSA-18 Questionnaire and Children's Health Questionnaire (CHQ-28)
HR-QOL forms OSA-18 and CHQ-28 to be completed by subjects at the time of enrollment, and at thereafter at three and six months. Main outcome measure is the difference or change from baseline.
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startFeb 2011
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of The King's Daughters
- Responsible party
- Sponsor
- Investigators
- Cristina M. Baldassari, MD, Principal investigator, Eastern Virginia Medical School Dept. of Otolaryngology-Head & Neck Surgery; Children's Hospital of the King's Daughters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539278
- Sponsor's protocol ID
- 10-12-FB-0266
- Status last verified
- Aug 2015
- First submitted
- 16 Feb 2012
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Baldassari CM, Mitchell RB, Schubert C, Rudnick EF. Pediatric obstructive sleep apnea and quality of life: a meta-analysis. Otolaryngol Head Neck Surg. 2008 Mar;138(3):265-273. doi: 10.1016/j.otohns.2007.11.003.
PubMed 18312869Calhoun SL, Mayes SD, Vgontzas AN, Tsaoussoglou M, Shifflett LJ, Bixler EO. No relationship between neurocognitive functioning and mild sleep disordered breathing in a community sample of children. J Clin Sleep Med. 2009 Jun 15;5(3):228-34.
PubMed 19960643Darrow DH. Surgery for pediatric sleep apnea. Otolaryngol Clin North Am. 2007 Aug;40(4):855-75. doi: 10.1016/j.otc.2007.04.008.
PubMed 17606027Friedman M, Wilson M, Lin HC, Chang HW. Updated systematic review of tonsillectomy and adenoidectomy for treatment of pediatric obstructive sleep apnea/hypopnea syndrome. Otolaryngol Head Neck Surg. 2009 Jun;140(6):800-8. doi: 10.1016/j.otohns.2009.01.043.
PubMed 19467393Giles TL, Lasserson TJ, Smith BH, White J, Wright J, Cates CJ. Continuous positive airways pressure for obstructive sleep apnoea in adults. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD001106. doi: 10.1002/14651858.CD001106.pub3.
PubMed 16855960Gozal D. Sleep, sleep disorders and inflammation in children. Sleep Med. 2009 Sep;10 Suppl 1:S12-6. doi: 10.1016/j.sleep.2009.07.003. Epub 2009 Jul 31.
PubMed 19647481Katz ES, D'Ambrosio CM. Pediatric obstructive sleep apnea syndrome. Clin Chest Med. 2010 Jun;31(2):221-34. doi: 10.1016/j.ccm.2010.02.002.
PubMed 20488283Li AM, Au CT, Ng SK, Abdullah VJ, Ho C, Fok TF, Ng PC, Wing YK. Natural history and predictors for progression of mild childhood obstructive sleep apnoea. Thorax. 2010 Jan;65(1):27-31. doi: 10.1136/thx.2009.120220. Epub 2009 Sep 23.
PubMed 19776090Mitchell RB, Kelly J. Behavioral changes in children with mild sleep-disordered breathing or obstructive sleep apnea after adenotonsillectomy. Laryngoscope. 2007 Sep;117(9):1685-8. doi: 10.1097/MLG.0b013e318093edd7.
PubMed 17667138van Staaji BK, van den Akker EH, Rovers MM, Hordijk GJ, Hoes AW, Schilder AG. Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial. Clin Otolaryngol. 2005 Feb;30(1):60-3. doi: 10.1111/j.1365-2273.2005.00980.x.
PubMed 15748193Wagner MH, Torrez DM. Interpretation of the polysomnogram in children. Otolaryngol Clin North Am. 2007 Aug;40(4):745-59. doi: 10.1016/j.otc.2007.04.004.
PubMed 17606021
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adenotonsillectomy on Quality of Life in Children With Mild Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01539278
- Acronym / sponsor ID
- 10-12-FB-0266
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Sleep Apnea, Obstructive, Child, Tonsillectomy, Adenoidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- Children's Hospital of The King's Daughters
- Study start
- Feb 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 Feb 2012 (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.
In children, enlarged adenoids and/or tonsils are the most common cause of obstructive sleep apnea (OSA), which is temporary blockage of breathing during sleep. Surgery to remove the tonsils and adenoids is the first-line treatment for disorder, and has been shown to cure the majority of children. However, for children with only a mild degree of OSA and few symptoms, surgery is less clear-cut, since two-thirds of these children do not develop worsening disease.
Research shows that some children with mild OSA and behavior problems are helped by removing the tonsils and adenoids. In children with all degrees of OSA, surgery has improved scores on tests that measure quality of life (QOL).
The investigators hypothesize that children with mild OSA will demonstrate changes on QOL assessment following adenotonsillectomy. These findings may help to guide the surgeon in selecting the children with mild OSA who are more likely to benefit from surgery.
Detailed description
Obstructive sleep apnea (OSA) is a sleep-related breathing disorder that is characterized by intermittent episodes of upper airway collapse and cessation of airflow during sleep. It comprises the severest extent of a spectrum of sleep disordered breathing (SDB) which includes primary snoring and upper airway resistance syndrome. OSA is a cause cardiovascular morbidity in adults and children and a public health concern, affecting 2-4% of the middle aged population (Giles 2009) and 2-3% of children in the United States (Katz 2010). It is further associated with an increased mortality risk in adults (Giles 2009) and well-described metabolic, cardiovascular, and neuropsychological deficits in children (Katz 2010). The latter symptoms include changes in behavior, memory and cognition, and poor school performance.
In children, adenotonsillar hyperplasia is uniformly the most common cause of upper airway obstruction, and the first-line therapy for these children is adenotonsillectomy (Darrow 2007). While its effectiveness is complicated by children with obesity and other comorbidities, the most recent analyses of outcomes using postsurgical apnea-hypopnea index reveal that adenotonsillectomy alone is able to cure approximately 60% of child OSA (Friedman 2010). Improvements have also been shown with neuropsychological outcomes such as behavior, school performance, attention, and others. (Katz 2010).
"Mild OSA" is an evolving definition; it is characterized by the polysomnographic finding of AHI range greater than 1 and less than 5, defined by Katz and Marcus.(Wagner 2007) This range corresponds to the difference in the defined pathological minimum AHI for children (normal AHI < 1) and adults (normal AHI < 5). In practice, "mild OSA" remains a common reason for delaying adenotonsillectomy in an otherwise asymptomatic child, since children with mild OSA have been shown to exhibit neurocognitive functioning equivalent to controls.(Calhoun 2009) However, psychosocially these children often have problems, and adenotonsillectomy has been shown to improve these children's behavior as measured by atypicality, depression, hyperactivity, and somatization.(Mitchell 2007) Furthermore, among one-third of children with mild OSA, the natural history is progression of disease.(Li 2010)
Psychosocial problems also become manifest using health-related quality-of-life (QOL) symptom scores. The study of QOL in children with OSA has become an area of scholarly interest in the last 15 years. It was only in 2000 that an OSA-specific QOL questionnaire was first developed and validated for use in children (2000 Franco). A recent meta-analysis of QOL following adenotonsillectomy revealed significant improvements in QOL scores in patients undergoing surgery for all severity levels of OSA.(2008 Baldassari) This meta-analysis included studies using validated QOL instruments, namely the Child Health Questionnaire (CHQ) and OSA-18.
Only one study of QOL in children with mild OSA found no clinically significant differences between patients who underwent adenotonsillectomy and controls; however, disease-specific QOL instrument (such as the OSA-18) was not used.(van Staaij 2004)
The investigators hypothesize that children with mild OSA will demonstrate changes on QOL assessment following adenotonsillectomy, particularly in OSA-specific domains. If true, a threshold for preoperative QOL scores may serve as a relative indication for adenotonsillectomy in the setting of mild OSA, independent of behavioral issues.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation, no surgery (control) | Active comparator | Other: Observation alone / no interventionPatients have been diagnosed with mild OSA, no intervention is done; enrolled patients may be randomly or nonrandomly placed in this group |
| Surgery (adenotonsillectomy) | Experimental | Procedure: AdenotonsillectomyPatients who have been diagnosed with mild OSA. Patient may be randomly assigned or non-randomly choose to be in this group; all undergo adenotonsillectomy |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Any obstructive breathing symptoms such as snoring, mouth-breathing, sleep pauses, gasping, restless sleep, witnessed apneas, daytime somnolence, and enuresis.
- Children between the ages of 3-16 years of age that have had a sleep study with an Apnea Hypopnea Index (AHI) score of 1 to 5.
Key exclusion criteria (6 listed)
- Subject/LAR unwillingness to comply with all study procedures
- Prior otolaryngologic surgery
- Prior sleep study
- Pregnant or breastfeeding
- Under 3 years of age and older than 16 years of age
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 |
|---|---|---|
| AdenotonsillectomyAlso: T&ATonsils and adenoids are surgically removed | Procedure or surgery | Surgery (adenotonsillectomy) |
| Observation alone / no interventionPatients are observed over time, no surgery is done, subjects complete QOL questionnaires at set intervals | Other | Observation, no surgery (control) |
Primary outcome
Change in Health-related Quality of Life (HR-QOL) from baseline, as measured by the OSA-18 Questionnaire and Children's Health Questionnaire (CHQ-28)
Time frame: baseline, 3 months, 6 months
HR-QOL forms OSA-18 and CHQ-28 to be completed by subjects at the time of enrollment, and at thereafter at three and six months. Main outcome measure is the difference or change from baseline.
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 5 Aug 2015.
- Background: PubMed 18312869Baldassari CM, Mitchell RB, Schubert C, Rudnick EF. Pediatric obstructive sleep apnea and quality of life: a meta-analysis. Otolaryngol Head Neck Surg. 2008 Mar;138(3):265-273. doi: 10.1016/j.otohns.2007.11.003.
- Background: PubMed 19960643Calhoun SL, Mayes SD, Vgontzas AN, Tsaoussoglou M, Shifflett LJ, Bixler EO. No relationship between neurocognitive functioning and mild sleep disordered breathing in a community sample of children. J Clin Sleep Med. 2009 Jun 15;5(3):228-34.
- Background: PubMed 17606027Darrow DH. Surgery for pediatric sleep apnea. Otolaryngol Clin North Am. 2007 Aug;40(4):855-75. doi: 10.1016/j.otc.2007.04.008.
- Background: PubMed 19467393Friedman M, Wilson M, Lin HC, Chang HW. Updated systematic review of tonsillectomy and adenoidectomy for treatment of pediatric obstructive sleep apnea/hypopnea syndrome. Otolaryngol Head Neck Surg. 2009 Jun;140(6):800-8. doi: 10.1016/j.otohns.2009.01.043.
- Background: PubMed 16855960Giles TL, Lasserson TJ, Smith BH, White J, Wright J, Cates CJ. Continuous positive airways pressure for obstructive sleep apnoea in adults. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD001106. doi: 10.1002/14651858.CD001106.pub3.
- Background: PubMed 19647481Gozal D. Sleep, sleep disorders and inflammation in children. Sleep Med. 2009 Sep;10 Suppl 1:S12-6. doi: 10.1016/j.sleep.2009.07.003. Epub 2009 Jul 31.
- Background: PubMed 20488283Katz ES, D'Ambrosio CM. Pediatric obstructive sleep apnea syndrome. Clin Chest Med. 2010 Jun;31(2):221-34. doi: 10.1016/j.ccm.2010.02.002.
- Background: PubMed 19776090Li AM, Au CT, Ng SK, Abdullah VJ, Ho C, Fok TF, Ng PC, Wing YK. Natural history and predictors for progression of mild childhood obstructive sleep apnoea. Thorax. 2010 Jan;65(1):27-31. doi: 10.1136/thx.2009.120220. Epub 2009 Sep 23.
- Background: PubMed 17667138Mitchell RB, Kelly J. Behavioral changes in children with mild sleep-disordered breathing or obstructive sleep apnea after adenotonsillectomy. Laryngoscope. 2007 Sep;117(9):1685-8. doi: 10.1097/MLG.0b013e318093edd7.
- Background: PubMed 15748193van Staaji BK, van den Akker EH, Rovers MM, Hordijk GJ, Hoes AW, Schilder AG. Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial. Clin Otolaryngol. 2005 Feb;30(1):60-3. doi: 10.1111/j.1365-2273.2005.00980.x.
- Background: PubMed 17606021Wagner MH, Torrez DM. Interpretation of the polysomnogram in children. Otolaryngol Clin North Am. 2007 Aug;40(4):745-59. doi: 10.1016/j.otc.2007.04.004.
Related trials for Sleep Apnea, Obstructive
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
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.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Cristina M. Baldassari, MD principal investigator
Eastern Virginia Medical School Dept. of Otolaryngology-Head & Neck Surgery; Children's Hospital of the King's Daughters
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adenotonsillectomy in people with Sleep Apnea, Obstructive, run by Eastern Virginia Medical School 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 2 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 5 Aug 2015. 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?
Change in Health-related Quality of Life (HR-QOL) from baseline, as measured by the OSA-18 Questionnaire and Children's Health Questionnaire (CHQ-28) (time frame: baseline, 3 months, 6 months). 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 NCT01539278, which also lists 11 linked publications.
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 5 Aug 2015.