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Endoscopic Classification and DISE-Guided Surgery in Pediatric Obstructive Sleep-Disordered Breathing.

Key facts

Who runs it
Regional Hospital West Jutland
Where
Denmark1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
250 people, planned
Started
1 Jan 2025
Expected to end
1 Jul 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Drug-induced Sleep Endoscopy findings (identified obstruction sites)
Record updated
23 October 2023

Who can take part

Age
2 years to 12 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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 take part

  • Previous surgery of the nose/pharynx/larynx
  • Syndromes and congenital/acquired craniofacial abnormalities/malformations of the upper airways
  • Neurological conditions affecting upper airway muscle tone
  • Lower airway disease (tracheomalacia, asthma)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 12 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • DISE-guided treatment groupTreatment being tested

    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.

    Treatment: Drug-induced Sleep Endoscopy findings (identified obstruction sites)

  • Non-DISE-guided treatment groupExisting treatment, for comparison

    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.

    Treatment: Drug-induced Sleep Endoscopy findings (identified obstruction sites)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Endoscopic Classification of Airway Obstruction and Drug Induced Sleep Endoscopy-Guided Surgery in Children With Obstructive Sleep-Disordered Breathing.
Fit questions
Built from NCT06093802, who can take part
Record updated
23 October 2023