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Effect of early tonsillectomy and adenoidectomy combined with nasolabial muscle training on the direction of mandibular development in children with sleep-disordered breathing: a randomized, parallel controlled, open clinical trial

Effect of early tonsillectomy and adenoidectomy combined with nasolabial muscle training on the direction of mandibular development in children with sleep-disordered breathing: a randomized, parallel controlled, open clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043468
Enrollment
Unknown
Registered
2021-02-19
Start date
2021-02-19
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

sleep-disordered breathing

Interventions

Tonsillectomy and adenoidectomy group:Tonsillectomy and adenoidectomy
Tonsillectomy and adenoidectomy combined with nasolabial muscle training group:Tonsillectomy and adenoidectomy combined with nasolabial muscle training
Follow-up observation group:N/A

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 10 Years

Inclusion criteria

Inclusion criteria: (1) Aged 5-10 years; (2) According to the results of PSG, it was diagnosed as mild to moderate sleep apnea hypopnea syndrome (according to the International Classification of Sleep Disorders ICSD, mild: 1 < OAHI <= 5; moderate: 5 < OAHI <= 10; OAHI, obstructive apnea hypopnea index); (3) Hypertrophy of tonsils and adenoids; (4) After multidisciplinary consultation with otolaryngologists, orthodontists, and sleep medicine physicians, the child does not meet the absolute indications for tonsillectomy and adenoidectomy and can tolerate the operation.

Exclusion criteria

Exclusion criteria: (1) Maxillofacial congenital malformations, history of maxillofacial surgery, or history of orthodontic treatment; (2) Extremely obese (Z value >= 3 [BMI- mean(bmi)] / sd(bmi)]); (3) Other diseases that affect the upper airway, such as nasal polyps, tumors, etc.; (4) Patients with clear surgical indications such as recurrent tonsillitis and suppuration; (5) Developmental delay and receive treatment; (6) Unable to cooperate with treatment.

Design outcomes

Primary

MeasureTime frame
mandibular plane angle;

Countries

China

Contacts

Public ContactMin Zhu

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

zminnie@126.com+86 18916093273

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026