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A Randomized Controlled Trial Comparing Medication Alone and Medication Combined with Rapid Palatal Expansion on Adenoid Size and Clinical Outcomes in Pediatric Obstructive Sleep Apnea

A Randomized Controlled Trial Comparing Medication Alone and Medication Combined with Rapid Palatal Expansion on Adenoid Size and Clinical Outcomes in Pediatric Obstructive Sleep Apnea

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260718002
Enrollment
30
Registered
2026-07-18
Start date
2026-06-16
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient age 6 to 12 years old who are diagnosed with pediatric obstructive sleep apnea (POSA) with AHI is greater than or equal to 5 confirmed by type III polysomnography Medication Rapid Palatal Expansion (RPE) Pediatric Obtructive Sleep Apnea

Interventions

Patients will be referred to the Department of Otolaryngology, Faculty of Medicine, Chiang Mai University, where otolaryngologists will evaluate each patient and prescribe the appropriate medical trea

Sponsors

Faculty of Dentistry Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Male and female volunteers 2. Aged between 6 to 12 years 3. Cervical vertebral maturation stage at CVMS 2 or CVMS 3 as assessed on the lateral cephalometric radiograph 4. Signs and symptoms of pediatric obstructive sleep apnea (POSA) with an apnea-hypopnea index (AHI) is greater than or equal to 5 confirmed by type III polysomnography 5. Adenoid hypertrophy as determined by an adenoidal-nasopharyngeal (A/N) ratio is greater than or equal to 60 (indicating significant adenoidal hypertrophy ) 6. Maxillary constriction with or without posterior crossbite, as assessed by cone-beam computed tomography (maxillomandibular width difference less than -4.1 mm ) 7. No prior treatment for adenoid hypertrophy

Exclusion criteria

Exclusion criteria: 1. Patients with craniofacial syndrome 2. Patients without maxillary constriction 3. Patients who do not consent to participate in the study 4. Patients with a history of prior orthodontic treatment 5. Patients with a history of prior adenoid surgery 6. Patients with claustrophobia who refused in process of CBCT 7. Patients deemed unable to cooperate with study procedures, as assessed by the treating clinician at the time of screening

Design outcomes

Primary

MeasureTime frame
Sleep quality: objective symptoms 6 months after end of treatment The apnea-hypopnea index

Secondary

MeasureTime frame
3D Anatomical outcome 6 months after end of treatment Adenoid volume,Clinical decision outcome 6 months after end of treatment Need for adenoid surgery,Sleep quality: subjective symptoms 6 months after end of the treatment Pediatric Sleep Questionnaire (PSQ score),Quality of life 6 months after end of the treatment OSA-18 questionnaire

Countries

Thailand

Contacts

Public ContactDr.Puttipong Sripinun

Faculty of Dentistry, Chiang Mai University

Puttipong.s@cmu.ac.th0624694645

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026