Sleep Apnea, ObstructiveNCT02315911
Randomized Control Trials of Surgery for Pediatric OSA
A study testing ATE and APP in people with Sleep Apnea, Obstructive and Otorhinolaryngologic Diseases, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Randomized study on pediatric OSA with 2 groups: mild-moderate OSA and severe OSA. Mild-moderate are randomized to either expectancy or ATE. Severe are randomized to either ATE or APP. Pediatric age span of 2 until 4,9 years. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Otorhinolaryngologic Diseases, Pediatric Disorder
- What is being tested?
- ATE and APP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2014to Mar 2019
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- OAHI >= 2
- Tonsillary hypertrophy, Brodsky size 2-4
- Adequate swedish knowledge
Who cannot join
- Cardiovascular disorders
- Pulmonary disorders
- Neuromuscular disorders
- Cranoifacial malformations
- Genetic disorders
- Earlier performed adenoid-tonsillary-surgery
- Bleeding disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Studies of Sugery for Pediatric OSA: Part 1 Expectancy Compared to Adeno-tonsillectomy for Mild-moderate OSA. Part 2 Adeno-tonsillectomy Compared to Adeno-pharyngoplasty for Severe OSA.
Randomized study on pediatric OSA with 2 groups: mild-moderate OSA and severe OSA. Mild-moderate are randomized to either expectancy or ATE. Severe are randomized to either ATE or APP. Pediatric age span of 2 until 4,9 years.
Read the detailed description
Children who are referred to ENT clinic because of sleep-disordered breathing and fulfil the inclusion criteria undergo polysomnography (PSG) and fill in questionnaires. Depending on the outcome of the PSG, whether a) the child have mild to moderate OSA (AHI between 2-9.9) the family is asked to be in the study. If yes, the doctor take a sealed envelope and open it, either the child are randomized to adenotonsillectomy (ATE) or 6 months expectancy. Whether PSG shows b) severe OSA and the family accept participation the child is operated within a month. There is a straification beetween 2 groups, if AHI is 1) between 10 and 29.9 or 2) above 30. A sealed envelope is open in the operating room by the surgeon. The child is randomized to either ATE or ATE and suturing of the tonsillar pillars. The study is blinded for the family, who will not know which method the child has undergone. After 6 months all children will undergo follow-up with PSG and questionnaires. If the expectancy group will deteriorate during waiting time, or the child still has moderate to severe OSA, they will undergo ATE. Further follow-ups at three and ten years. Altogether 160 children should be evaluated with two PSG, 80 in each group.
- Being tested
- ATE, APP
- Keywords
- Tonsillectomy, Adenoidectomy, Adenoidpharyngoplasty, OSA
- Medical subject headings
- Sleep Apnea, Obstructive, Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATEProcedure or surgery
Also called adeno-tonsillectomy
surgical removal of adenoids and tonsils
APPProcedure or surgery
Also called adeno-pharyngoplasty
surgical removal of adenoids and tonsils and suturing of palatal pillars
| Study group | Role | What they receive |
|---|---|---|
| expectancy for mild-moderate OSA | No intervention | 6 months expectancy |
| ATE for mild-moderate OSA | Experimental | adeno-tonsillectomy Receives: Procedure: ATE |
| ATE for severe OSA | Experimental | adeno-tonsillectomy Receives: Procedure: ATE |
| APP for severe OSA | Experimental | adeno-pharyngoplasty Receives: Procedure: APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
obstructive apnea hypopnea index
with full-night polysomnography
Measured: 6 months
Secondary outcomes (6)
oxygen desaturation index
with full-night polysomnography
Measured: 6 months
postoperative pain
visuell analog scale, questionnaire diaries. Number of days until normal diet.
Measured: 6 months
per- and postoperative bleeding
description of bleeding amount per and postoperatively, number of patients needed to reoperate because of bleeding postoperatively
Measured: postoperatively, weeks
quality of life
Questionnaires validated, SDQ and OSA-18
Measured: 6 months
Innate lymphoid cells in tonsils
To investigate the amount of Innate lymphoid cells in children with OSA
Measured: 6 months
side-effects of surgery
with a questionnaire evaluate if the child postoperatively will have speech-or swallowing difficulties. The parents will respond with a four-point Likert scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 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
- Bo Tideholm, Study director, ENT-clinic, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315911
- Sponsor's protocol ID
- NCT02315911
- Status last verified
- Apr 2019
- First submitted
- 8 Dec 2014
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sjolander I, Fehrm J, Borgstrom A, Nerfeldt P, Friberg D. Adenotonsillectomy vs Watchful Waiting in Pediatric Mild to Moderate Obstructive Sleep Apnea: The KATE Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Nov 1;151(11):1038-1045. doi: 10.1001/jamaoto.2025.2831.
PubMed 40965870Fehrm J, Nerfeldt P, Browaldh N, Friberg D. Effectiveness of Adenotonsillectomy vs Watchful Waiting in Young Children With Mild to Moderate Obstructive Sleep Apnea: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2020 Jul 1;146(7):647-654. doi: 10.1001/jamaoto.2020.0869.
PubMed 32463430Fehrm J, Nerfeldt P, Sundman J, Friberg D. Adenopharyngoplasty vs Adenotonsillectomy in Children With Severe Obstructive Sleep Apnea: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Jul 1;144(7):580-586. doi: 10.1001/jamaoto.2018.0487.
PubMed 29852045
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Studies of Sugery for Pediatric OSA: Part 1 Expectancy Compared to Adeno-tonsillectomy for Mild-moderate OSA. Part 2 Adeno-tonsillectomy Compared to Adeno-pharyngoplasty for Severe OSA.
- ClinicalTrials.gov ID
- NCT02315911
- Acronym / sponsor ID
- NCT02315911
- Keywords
- Tonsillectomy, Adenoidectomy, Adenoidpharyngoplasty, OSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 12 Dec 2014 (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.
Randomized study on pediatric OSA with 2 groups: mild-moderate OSA and severe OSA. Mild-moderate are randomized to either expectancy or ATE. Severe are randomized to either ATE or APP. Pediatric age span of 2 until 4,9 years.
Detailed description
Children who are referred to ENT clinic because of sleep-disordered breathing and fulfil the inclusion criteria undergo polysomnography (PSG) and fill in questionnaires. Depending on the outcome of the PSG, whether a) the child have mild to moderate OSA (AHI between 2-9.9) the family is asked to be in the study. If yes, the doctor take a sealed envelope and open it, either the child are randomized to adenotonsillectomy (ATE) or 6 months expectancy. Whether PSG shows b) severe OSA and the family accept participation the child is operated within a month. There is a straification beetween 2 groups, if AHI is 1) between 10 and 29.9 or 2) above 30. A sealed envelope is open in the operating room by the surgeon. The child is randomized to either ATE or ATE and suturing of the tonsillar pillars. The study is blinded for the family, who will not know which method the child has undergone. After 6 months all children will undergo follow-up with PSG and questionnaires. If the expectancy group will deteriorate during waiting time, or the child still has moderate to severe OSA, they will undergo ATE. Further follow-ups at three and ten years. Altogether 160 children should be evaluated with two PSG, 80 in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| expectancy for mild-moderate OSA | No intervention | –6 months expectancy |
| ATE for mild-moderate OSA | Experimental | Procedure: ATEadeno-tonsillectomy |
| ATE for severe OSA | Experimental | Procedure: ATEadeno-tonsillectomy |
| APP for severe OSA | Experimental | Procedure: APPadeno-pharyngoplasty |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- OAHI >= 2
- Tonsillary hypertrophy, Brodsky size 2-4
- Adequate swedish knowledge
Key exclusion criteria (7 listed)
- Cardiovascular disorders
- Pulmonary disorders
- Neuromuscular disorders
- Cranoifacial malformations
- Genetic disorders
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 |
|---|---|---|
| ATEAlso: adeno-tonsillectomysurgical removal of adenoids and tonsils | Procedure or surgery | ATE for mild-moderate OSA, ATE for severe OSA |
| APPAlso: adeno-pharyngoplastysurgical removal of adenoids and tonsils and suturing of palatal pillars | Procedure or surgery | APP for severe OSA |
Primary outcome
obstructive apnea hypopnea index
Time frame: 6 months
with full-night polysomnography
6 secondary outcomes
oxygen desaturation index
Time frame: 6 months
postoperative pain
Time frame: 6 months
per- and postoperative bleeding
Time frame: postoperatively, weeks
quality of life
Time frame: 6 months
Innate lymphoid cells in tonsils
Time frame: 6 months
side-effects of surgery
Time frame: 6 months
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 8 Apr 2019.
- Derived from this study: PubMed 40965870Sjolander I, Fehrm J, Borgstrom A, Nerfeldt P, Friberg D. Adenotonsillectomy vs Watchful Waiting in Pediatric Mild to Moderate Obstructive Sleep Apnea: The KATE Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Nov 1;151(11):1038-1045. doi: 10.1001/jamaoto.2025.2831.
- Derived from this study: PubMed 32463430Fehrm J, Nerfeldt P, Browaldh N, Friberg D. Effectiveness of Adenotonsillectomy vs Watchful Waiting in Young Children With Mild to Moderate Obstructive Sleep Apnea: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2020 Jul 1;146(7):647-654. doi: 10.1001/jamaoto.2020.0869.
- Derived from this study: PubMed 29852045Fehrm J, Nerfeldt P, Sundman J, Friberg D. Adenopharyngoplasty vs Adenotonsillectomy in Children With Severe Obstructive Sleep Apnea: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Jul 1;144(7):580-586. doi: 10.1001/jamaoto.2018.0487.
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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.
Bo Tideholm study director
ENT-clinic, Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATE and APP in people with Sleep Apnea, Obstructive and Otorhinolaryngologic Diseases, 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 3 inclusion and 7 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 8 Apr 2019. 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?
obstructive apnea hypopnea index (time frame: 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 NCT02315911, which also lists 3 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 8 Apr 2019.