NCT06093802

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
39mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Jan 2025Jul 2029

First Submitted

Initial submission to the registry

October 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Expected
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 11, 2023

Last Update Submit

October 17, 2023

Conditions

Obstructive Sleep Apnea of Child

Keywords

Drug-induced Sleep Endoscopy

Outcome Measures

Primary Outcomes (1)

  • 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).

    one year post surgery

Secondary Outcomes (4)

  • DISE findings

    initial assessment and one year post surgery

  • OSA (AHI)

    initial assessment and one year post surgery

  • Quality of Life (OSA-18)

    initial assessment and one year post surgery

  • Sedation-related and surgical complications

    initial assessment and one year post surgery

Study Arms (2)

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.

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.

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

Interventions

Drug-induced Sleep Endoscopy findings (identified obstruction sites)DIAGNOSTIC_TEST

As described above

Also known as: Turbinoplasty, Nasal steroids
DISE-guided treatment groupNon-DISE-guided treatment group

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Hospital Gødstrup

Herning, Region of Central Jutland, 7400, Denmark

Location

Study Officials

  • Therese E Ovesen, Prof. DMSc

    Regional Hospital West Jutland

    STUDY DIRECTOR

Central Study Contacts

Mascha Hildebrandt, MD

CONTACT

+4541289051mascha.hilde@gmail.com

Jannik Bertelsen, MD PhD

CONTACT

jannik.bertelsen@auh.rm.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 23, 2023

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

July 1, 2029

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

DK(1)