Obstructive Sleep Apnea Syndrome in ChildrenRCT ATE/ATTNCT01676181
ATT Compared With ATE in OSAS Children
A study testing Adenotonsillectomy and Adenotonsillotomy in people with Obstructive Sleep Apnea Syndrome in Children, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome in Children
- What is being tested?
- Adenotonsillectomy and Adenotonsillotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2011to Mar 2017
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2-6 years
- Clinical symptoms of OSAS (apneas, snoring, disturbed sleep)
- Tonsil size 3-4 with the Brodsky scale (obstructing at least 50% of the oro-pharyngeal space)
- Apnea-Hypopnea Index (AHI) 5-30 (moderate- severe OSA)
Who cannot join
- Clinical signs of craniofacial anomalies or neuromuscular disorders
- Obesity
- Earlier having had surgery of tonsils or adenoid
- Bleeding disorder
- Cardiopulmonary disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Surgical Intervention Study Between Adenotonsillectomy and Adenotonsillotomy in Children With Obstructive Sleep Apnea Syndrome
Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.
Read the detailed description
Background: Children with obstructive sleep apnea syndrome (OSAS) have apneas and disturbed sleep, which causes daytime symptoms such as neurobehavioral problems. OSAS is a significant cause of morbidity among children with an incidence of 1-3%, and a peak prevalence at 2-5 years of age. If left untreated it can cause severe complications including failure to thrive, cardiovascular complications, metabolic conditions and neurobehavioral disturbances (eg hyperactivity, inattention).
Golden standard to diagnose OSA in children is full-night polysomnography (PSG) at a sleep laboratory including EEG, EOG, EMG, video-audiometry and respiratory recordings. At the Department of Otorhinolaryngology at Karolinska University Hospital, we have a sleep laboratory performing in-lab full-night polysomnography.
The cause of OSAS in children is usually adenotonsillar hypertrophy, and the treatment of choice is surgical removal of tonsils and adenoid. Traditionally total adenotonsillectomy (ATE) has been performed, but in the last decade an alternative surgical method with partial adenotonsillotomy (ATT) is developed, where only the medial portion of the tonsil is removed. The newer method ATT is not fully evaluated in comparison with traditional ATE. There are studies comparing evaluating post-operative pain and bleeding showing a slight advantage for the TT-method. Very few studies are performed using objectively measured PSG-parameters to evaluate the effect of surgery on the sleep fragmentation and the sleep apneas. There is a need for such studies in the field of surgical treatment of pediatric OSA. This was also stated in a Cochrane database review from 2009, in which the conclusion was that there is a need for high quality randomised controlled trials to be carried out investigating the efficacy of surgical treatment of OSA in children. This makes this study important and of high clinical interest.
Aims: To increase the knowledge of pediatric OSA and its treatment and to optimize the surgical treatment for children with OSA.
To through a blinded randomized controlled trial compare the efficacy of ATT and ATE in treating OSA in children, including long-term follow-up after one, three and ten years.
To evaluate postoperative pain after ATE and ATT. To evaluate quality of life after ATE and ATT.
- Being tested
- Adenotonsillectomy, Adenotonsillotomy
- Keywords
- Obstructive sleep apnea syndrome, Children, Polysomnography, Surgery, Coblation, Tonsils, Tonsillectomy
- 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
Total removal of tonsils and adenoid tissue with cold-steel
AdenotonsillotomyProcedure or surgery
Partial removal of tonsils with coblation and total removal of adenoids with cold steel
| Study group | Role | What they receive |
|---|---|---|
| Adenotonsillectomy | Active comparator | Total removal of tonsils and adenoids with cold steel Receives: Procedure: Adenotonsillectomy |
| Adenotonsillotomy | Active comparator | Partial removal of tonsils with coblation and total removal of adenoids with cold steel Receives: Procedure: Adenotonsillotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in polysomnographic parameter AHI (Apnea Hypopnea Index)
AHI; the number of apneas and hypopneas per sleep hour, is measured through polysomnography before and after surgery.
Measured: One, three and ten years
Secondary outcomes (1)
Changes in quality of life questionnaires (OSA18 and SDQ)
Parents answering to quality of life-questionnaire OSA18 and SDQ (Strengths and Difficulties Questionnaire) before and after surgical intervention
Measured: One, three and ten Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startNov 2011
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea Syndrome in ChildrenStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Friberg, Karolinska University Hospital
- Investigators
- Danielle Friberg, MD, PhD, Principal investigator, Karolinska University Hospital, ORL dep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676181
- Sponsor's protocol ID
- 2011/333-31/4
- Acronym
- RCT ATE/ATT
- Status last verified
- Mar 2023
- First submitted
- 21 Aug 2012
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Blackshaw H, Springford LR, Zhang LY, Wang B, Venekamp RP, Schilder AG. Tonsillectomy versus tonsillotomy for obstructive sleep-disordered breathing in children. Cochrane Database Syst Rev. 2020 Apr 29;4(4):CD011365. doi: 10.1002/14651858.CD011365.pub2.
PubMed 32347984Borgstrom A, Nerfeldt P, Friberg D. Postoperative pain and bleeding after adenotonsillectomy versus adenotonsillotomy in pediatric obstructive sleep apnea: an RCT. Eur Arch Otorhinolaryngol. 2019 Nov;276(11):3231-3238. doi: 10.1007/s00405-019-05571-w. Epub 2019 Aug 3.
PubMed 31377901
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Surgical Intervention Study Between Adenotonsillectomy and Adenotonsillotomy in Children With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT01676181
- Acronym / sponsor ID
- RCT ATE/ATT / 2011/333-31/4
- Keywords
- Obstructive sleep apnea syndrome, Children, Polysomnography, Surgery, Coblation, Tonsils, Tonsillectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 30 Aug 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.
Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.
Detailed description
Background: Children with obstructive sleep apnea syndrome (OSAS) have apneas and disturbed sleep, which causes daytime symptoms such as neurobehavioral problems. OSAS is a significant cause of morbidity among children with an incidence of 1-3%, and a peak prevalence at 2-5 years of age. If left untreated it can cause severe complications including failure to thrive, cardiovascular complications, metabolic conditions and neurobehavioral disturbances (eg hyperactivity, inattention).
Golden standard to diagnose OSA in children is full-night polysomnography (PSG) at a sleep laboratory including EEG, EOG, EMG, video-audiometry and respiratory recordings. At the Department of Otorhinolaryngology at Karolinska University Hospital, we have a sleep laboratory performing in-lab full-night polysomnography.
The cause of OSAS in children is usually adenotonsillar hypertrophy, and the treatment of choice is surgical removal of tonsils and adenoid. Traditionally total adenotonsillectomy (ATE) has been performed, but in the last decade an alternative surgical method with partial adenotonsillotomy (ATT) is developed, where only the medial portion of the tonsil is removed. The newer method ATT is not fully evaluated in comparison with traditional ATE. There are studies comparing evaluating post-operative pain and bleeding showing a slight advantage for the TT-method. Very few studies are performed using objectively measured PSG-parameters to evaluate the effect of surgery on the sleep fragmentation and the sleep apneas. There is a need for such studies in the field of surgical treatment of pediatric OSA. This was also stated in a Cochrane database review from 2009, in which the conclusion was that there is a need for high quality randomised controlled trials to be carried out investigating the efficacy of surgical treatment of OSA in children. This makes this study important and of high clinical interest.
Aims: To increase the knowledge of pediatric OSA and its treatment and to optimize the surgical treatment for children with OSA.
To through a blinded randomized controlled trial compare the efficacy of ATT and ATE in treating OSA in children, including long-term follow-up after one, three and ten years.
To evaluate postoperative pain after ATE and ATT. To evaluate quality of life after ATE and ATT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenotonsillectomy | Active comparator | Procedure: AdenotonsillectomyTotal removal of tonsils and adenoids with cold steel |
| Adenotonsillotomy | Active comparator | Procedure: AdenotonsillotomyPartial removal of tonsils with coblation and total removal of adenoids with cold steel |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 2-6 years
- Clinical symptoms of OSAS (apneas, snoring, disturbed sleep)
- Tonsil size 3-4 with the Brodsky scale (obstructing at least 50% of the oro-pharyngeal space)
- Apnea-Hypopnea Index (AHI) 5-30 (moderate- severe OSA)
Key exclusion criteria (5 listed)
- Clinical signs of craniofacial anomalies or neuromuscular disorders
- Obesity
- Earlier having had surgery of tonsils or adenoid
- Bleeding disorder
- Cardiopulmonary disorder
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 |
|---|---|---|
| AdenotonsillectomyTotal removal of tonsils and adenoid tissue with cold-steel | Procedure or surgery | Adenotonsillectomy |
| AdenotonsillotomyPartial removal of tonsils with coblation and total removal of adenoids with cold steel | Procedure or surgery | Adenotonsillotomy |
Primary outcome
Changes in polysomnographic parameter AHI (Apnea Hypopnea Index)
Time frame: One, three and ten years
AHI; the number of apneas and hypopneas per sleep hour, is measured through polysomnography before and after surgery.
1 secondary outcome
Changes in quality of life questionnaires (OSA18 and SDQ)
Time frame: One, three and ten Years
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 10 Mar 2023.
- Derived from this study: PubMed 32347984Blackshaw H, Springford LR, Zhang LY, Wang B, Venekamp RP, Schilder AG. Tonsillectomy versus tonsillotomy for obstructive sleep-disordered breathing in children. Cochrane Database Syst Rev. 2020 Apr 29;4(4):CD011365. doi: 10.1002/14651858.CD011365.pub2.
- Derived from this study: PubMed 31377901Borgstrom A, Nerfeldt P, Friberg D. Postoperative pain and bleeding after adenotonsillectomy versus adenotonsillotomy in pediatric obstructive sleep apnea: an RCT. Eur Arch Otorhinolaryngol. 2019 Nov;276(11):3231-3238. doi: 10.1007/s00405-019-05571-w. Epub 2019 Aug 3.
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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.
Danielle Friberg, MD, PhD principal investigator
Karolinska University Hospital, ORL dep
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 and Adenotonsillotomy in people with Obstructive Sleep Apnea Syndrome in Children, run by Karolinska University Hospital at 1 site in Sweden.
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 4 inclusion and 5 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 10 Mar 2023. 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 Sweden. 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?
Changes in polysomnographic parameter AHI (Apnea Hypopnea Index) (time frame: One, three and ten years). 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 NCT01676181, which also lists 2 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 10 Mar 2023.