Obstructive Sleep Apnea of ChildDISENCT06093802
Endoscopic Classification and DISE-Guided Surgery in Pediatric Obstructive Sleep-Disordered Breathing.
A study testing Drug-induced Sleep Endoscopy findings (identified obstruction sites) in people with Obstructive Sleep Apnea of Child, run by Regional Hospital West Jutland at 1 site in Denmark.
Trial summary
Pediatric obstructive sleep apnea (OSA) can lead to severe health issues if untreated. While polysomnography is the gold standard for diagnosis, current surgical treatment in Denmark relies on caregiver reports and clinical exams. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Obstructive Sleep Apnea of Child
- What is being tested?
- Drug-induced Sleep Endoscopy findings (identified obstruction sites)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2025to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Surgically naïve, otherwise healthy, non-syndromic children aged 2-12 years with suspected oSDB of any severity
- One completed Pediatric Sleep Questionnaire - Sleep Related Breathing Disorder (PSQ)
- Home Respiratory Polygraphy (HRP) and/or in-house Polysomnography (PSG) showing OSA according to the definition of AAO-HNSF
Who cannot join
- Syndromes and congenital/acquired craniofacial abnormalities/malformations of the upper airways
- Neurological conditions affecting upper airway muscle tone
- Lower airway disease (tracheomalacia, asthma)
- Previous surgery of the nose/pharynx/larynx
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jannik Bertelsen, MD PhD contact
Denmark1 site
Regional Hospital Gødstrup
Herning, Region of Central Jutland, 7400
Therese E Ovesen, Prof. DMSc, theroves@rm.dk
Anne Louise Bach Christensen, MD, anebch@rm.dk
About this study
Official title: Endoscopic Classification of Airway Obstruction and Drug Induced Sleep Endoscopy-Guided Surgery in Children With Obstructive Sleep-Disordered Breathing.
Pediatric obstructive sleep apnea (OSA) can lead to severe health issues if untreated. While polysomnography is the gold standard for diagnosis, current surgical treatment in Denmark relies on caregiver reports and clinical exams. Approximately 25% of patients have persistent symptoms post-surgery, indicating the need for better diagnostic and treatment options. Drug-Induced Sleep Endoscopy (DISE) allows dynamic upper airway visualization during mild sedation, aiding in treatment decisions. This research project aims to evaluate the impact of DISE-guided interventions on pediatric OSA outcomes and compare its effectiveness and cost/benefit with traditional diagnostic approaches.
Read the detailed description
Background
1.1 Pediatric Obstructive Sleep Apnea
Pediatric OSA ranges from simple snoring to severe upper airway obstruction during sleep. Left untreated, it can lead to significant health issues, especially in children, impacting their cognitive development, learning, and social interactions.
1.2 Diagnostics and Surgical Strategies
Polysomnography (PSG) is the gold standard for diagnosing OSA. In Denmark, PSG isn't widely used due to equipment and setup constraints.
Surgical treatment for pediatric OSA in Denmark relies primarily on clinical examination of the tonsils and parental reports of symptoms.
1.3 Drug-Induced Sleep Endoscopy (DISE)
DISE is a method for visualizing upper airway collapse during sleep using a flexible endoscope. It is increasingly used to guide surgical decisions for pediatric OSA in various countries, though its clinical impact remains uncertain.
- Aims
This research project aims to evaluate the impact of DISE-guided surgical interventions on pediatric OSA outcomes and compare the effectiveness of a DISE-inclusive diagnostic approach with the traditional pediatric OSA workup. The specific objectives are:
Evaluate treatment outcomes, including the reduction in persistent OSA post-surgery.
Classify and compare patterns of airway obstruction observed during DISE in surgically naive children.
Compare diagnostic approaches in terms of cost, time, and benefits. Identify adverse events and complications related to sedation and surgery. Assess the feasibility of DISE in Danish patients through a pilot study.
- Methods
3.1 Randomized Controlled Trial (RCT)
Patients undergo initial clinical examination and home respiratory polygraphy (HRP). Based on AAO-HNSF criteria, patients with OSA will undergo DISE. The sample size for the RCT is 250 patients, with 125 in each group.
3.2 Statistics
Statistical analysis will involve Chi-square tests, logistic regression, and T-tests for comparisons between groups.
3.3 Sedation Protocol
Sedation will use propofol to induce a state similar to natural sleep, guided by preoperative polysomnography.
3.4 Assessment of Obstruction
Obstruction characteristics will be documented using the International Pediatric Sleep Endoscopy Scale (IPSES).
3.5 Follow-up
Patients will have two follow-up appointments at three and 12 months postoperatively, including clinical examination, HRP, and re-DISE at three months for both groups.
- Outcomes
4.1 Primary Outcome
The primary outcome is the treatment failure rate, comparing the proportion of patients with persistent OSA post-surgery in the DISE-guided surgery group to the non-DISE-guided surgery group.
4.2 Secondary Outcomes
Secondary outcomes include evaluation of DISE findings, changes in apnea-hypopnea index (AHI), quality of life improvement, DISE-score/airway obstruction pattern, and identification of adverse events and complications.
4.3 Confounding Factors
Population characteristics, such as age, obesity (BMI), and gender, will be considered.
- Ethical Considerations
In cases where no obstruction is identified related to tonsils or adenoids, alternative treatment options will be discussed with parents. Privacy and informed consent are required. The study will follow ethical and data protection regulations
- Conditions
- Obstructive Sleep Apnea of Child
- Being tested
- Drug-induced Sleep Endoscopy findings (identified obstruction sites)
- Keywords
- Drug-induced Sleep Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-induced Sleep Endoscopy findings (identified obstruction sites)Diagnostic test
Also called Turbinoplasty, Nasal steroids
As described above
| Study group | Role | What they receive |
|---|---|---|
| DISE-guided treatment group | Experimental | DISE findings will be documented and obstruction scored per pediatric DISE criteria. Clinically relevant obstruction is defined as >50% at minimum one site. (Adeno-)tonsillotomy will be performed if corroborative DISE suggests tonsil/adenoid obstruction; if not, no surgery will be performed.
This approach is maintained despite other identified obstruction sites, which will be assessed at a later stage. Receives: Diagnostic Test: Drug-induced Sleep Endoscopy findings (identified obstruction sites) |
| Non-DISE-guided treatment group | Active comparator | DISE findings will be documented, and video material will be saved for later assessment.
Patients will be operated according to current guidelines (s.o.), regardless of perioperative DISE findings, i.e. tonsillotomy +/- adenoidectomy. Receives: Diagnostic Test: Drug-induced Sleep Endoscopy findings (identified obstruction sites) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure Rate
Proportion of patients, who exhibit persistent OSA post-surgery in the DISE-guided surgery group compared to the non-DISE-guided surgery group (controls).
Measured: one year post surgery
Secondary outcomes (4)
DISE findings
Evaluation of DISE findings and pediatric VOTE:
Assessing obstruction degree and sites in both groups.
Quality of Life Improvement:
DISE-score and Airway Obstruction Pattern:
Identifying and comparing anatomical obstruction sites and severity during DISE in both groups.
Measured: initial assessment and one year post surgery
OSA (AHI)
Change in apnea-hypopnea index (AHI):
Analyzing AHI and oxygen saturation differences between baseline and post-treatment in both groups.
Measured: initial assessment and one year post surgery
Quality of Life (OSA-18)
Evaluation of symptom changes and quality of life using the OSA-18 questionnaire in both groups.
Measured: initial assessment and one year post surgery
Sedation-related and surgical complications
Adverse Events and Complications:
Investigation of the incidence and severity of sedation-related events and surgical complications in both groups, including postoperative hemorrhage, infection, recurrent symptoms post-tonsillotomy, and symptom improvement without treatment.
Measured: initial assessment and one year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of ChildStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regional Hospital West Jutland
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Principal investigator, Mascha Eva Hildebrandt, Regional Hospital West Jutland
- Investigators
- Therese E Ovesen, Prof. DMSc, Study director, Regional Hospital West Jutland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093802
- Sponsor's protocol ID
- MHildebrandt
- Acronym
- DISE
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Classification of Airway Obstruction and Drug Induced Sleep Endoscopy-Guided Surgery in Children With Obstructive Sleep-Disordered Breathing.
- ClinicalTrials.gov ID
- NCT06093802
- Acronym / sponsor ID
- DISE / MHildebrandt
- Conditions
- Obstructive Sleep Apnea of Child
- Keywords
- Drug-induced Sleep Endoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Regional Hospital West JutlandUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 23 Oct 2023 (actual)
- 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.
Pediatric obstructive sleep apnea (OSA) can lead to severe health issues if untreated. While polysomnography is the gold standard for diagnosis, current surgical treatment in Denmark relies on caregiver reports and clinical exams. Approximately 25% of patients have persistent symptoms post-surgery, indicating the need for better diagnostic and treatment options. Drug-Induced Sleep Endoscopy (DISE) allows dynamic upper airway visualization during mild sedation, aiding in treatment decisions. This research project aims to evaluate the impact of DISE-guided interventions on pediatric OSA outcomes and compare its effectiveness and cost/benefit with traditional diagnostic approaches.
Detailed description
Background
1.1 Pediatric Obstructive Sleep Apnea
Pediatric OSA ranges from simple snoring to severe upper airway obstruction during sleep. Left untreated, it can lead to significant health issues, especially in children, impacting their cognitive development, learning, and social interactions.
1.2 Diagnostics and Surgical Strategies
Polysomnography (PSG) is the gold standard for diagnosing OSA. In Denmark, PSG isn't widely used due to equipment and setup constraints.
Surgical treatment for pediatric OSA in Denmark relies primarily on clinical examination of the tonsils and parental reports of symptoms.
1.3 Drug-Induced Sleep Endoscopy (DISE)
DISE is a method for visualizing upper airway collapse during sleep using a flexible endoscope. It is increasingly used to guide surgical decisions for pediatric OSA in various countries, though its clinical impact remains uncertain.
- Aims
This research project aims to evaluate the impact of DISE-guided surgical interventions on pediatric OSA outcomes and compare the effectiveness of a DISE-inclusive diagnostic approach with the traditional pediatric OSA workup. The specific objectives are:
Evaluate treatment outcomes, including the reduction in persistent OSA post-surgery.
Classify and compare patterns of airway obstruction observed during DISE in surgically naive children.
Compare diagnostic approaches in terms of cost, time, and benefits. Identify adverse events and complications related to sedation and surgery. Assess the feasibility of DISE in Danish patients through a pilot study.
- Methods
3.1 Randomized Controlled Trial (RCT)
Patients undergo initial clinical examination and home respiratory polygraphy (HRP). Based on AAO-HNSF criteria, patients with OSA will undergo DISE. The sample size for the RCT is 250 patients, with 125 in each group.
3.2 Statistics
Statistical analysis will involve Chi-square tests, logistic regression, and T-tests for comparisons between groups.
3.3 Sedation Protocol
Sedation will use propofol to induce a state similar to natural sleep, guided by preoperative polysomnography.
3.4 Assessment of Obstruction
Obstruction characteristics will be documented using the International Pediatric Sleep Endoscopy Scale (IPSES).
3.5 Follow-up
Patients will have two follow-up appointments at three and 12 months postoperatively, including clinical examination, HRP, and re-DISE at three months for both groups.
- Outcomes
4.1 Primary Outcome
The primary outcome is the treatment failure rate, comparing the proportion of patients with persistent OSA post-surgery in the DISE-guided surgery group to the non-DISE-guided surgery group.
4.2 Secondary Outcomes
Secondary outcomes include evaluation of DISE findings, changes in apnea-hypopnea index (AHI), quality of life improvement, DISE-score/airway obstruction pattern, and identification of adverse events and complications.
4.3 Confounding Factors
Population characteristics, such as age, obesity (BMI), and gender, will be considered.
- Ethical Considerations
In cases where no obstruction is identified related to tonsils or adenoids, alternative treatment options will be discussed with parents. Privacy and informed consent are required. The study will follow ethical and data protection regulations
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DISE-guided treatment group | Experimental | Diagnostic Test: Drug-induced Sleep Endoscopy findings (identified obstruction sites)DISE findings will be documented and obstruction scored per pediatric DISE criteria. Clinically relevant obstruction is defined as >50% at minimum one site. (Adeno-)tonsillotomy will be performed if corroborative DISE suggests tonsil/adenoid obstruction; if not, no surgery will be performed. This approach is maintained despite other identified obstruction sites, which will be assessed at a later stage. |
| Non-DISE-guided treatment group | Active comparator | Diagnostic Test: Drug-induced Sleep Endoscopy findings (identified obstruction sites)DISE findings will be documented, and video material will be saved for later assessment. Patients will be operated according to current guidelines (s.o.), regardless of perioperative DISE findings, i.e. tonsillotomy +/- adenoidectomy. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Surgically naïve, otherwise healthy, non-syndromic children aged 2-12 years with suspected oSDB of any severity
- One completed Pediatric Sleep Questionnaire - Sleep Related Breathing Disorder (PSQ)
- Home Respiratory Polygraphy (HRP) and/or in-house Polysomnography (PSG) showing OSA according to the definition of AAO-HNSF
Key exclusion criteria (4 listed)
- Syndromes and congenital/acquired craniofacial abnormalities/malformations of the upper airways
- Neurological conditions affecting upper airway muscle tone
- Lower airway disease (tracheomalacia, asthma)
- Previous surgery of the nose/pharynx/larynx
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 |
|---|---|---|
| Drug-induced Sleep Endoscopy findings (identified obstruction sites)Also: Turbinoplasty, Nasal steroidsAs described above | Diagnostic test | DISE-guided treatment group, Non-DISE-guided treatment group |
Primary outcome
Treatment Failure Rate
Time frame: one year post surgery
Proportion of patients, who exhibit persistent OSA post-surgery in the DISE-guided surgery group compared to the non-DISE-guided surgery group (controls).
4 secondary outcomes
DISE findings
Time frame: initial assessment and one year post surgery
OSA (AHI)
Time frame: initial assessment and one year post surgery
Quality of Life (OSA-18)
Time frame: initial assessment and one year post surgery
Sedation-related and surgical complications
Time frame: initial assessment and one year post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Obstructive Sleep Apnea of Child
RecruitingObservational study
Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
Obstructive Sleep Disordered Breathing
Not yet recruiting
Pediatric/Adolescent WatchPAT 400 Reliability Pilot Study
Pediatric Sleep Disordered Breathing, Obstructive Sleep Apnea
RecruitingObservational study
SUNOSI® (Solriamfetol) Pregnancy Registry
Narcolepsy, Obstructive Sleep Apnea
RecruitingObservational study
Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy?
Sleep Apnea, Obstructive
RecruitingPhase 2
Down Syndrome Obstructive Sleep Apnea
Down Syndrome, 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.
Jannik Bertelsen, MD PhD contact
Therese E Ovesen, Prof. DMSc study director
Regional Hospital West Jutland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-induced Sleep Endoscopy findings (identified obstruction sites) in people with Obstructive Sleep Apnea of Child, run by Regional Hospital West Jutland at 1 site in Denmark.
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 4 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: opening soon, as of the sponsor's last update on 23 Oct 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mascha Hildebrandt, MD (+4541289051, mascha.hilde@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Failure Rate (time frame: one year post surgery). 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 23 Oct 2023.