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Clinical and Mechanism Study of Modified Tonsil Cauterization in the Treatment of Obstructive Sleep Apnea Hypopnea Syndrome with Tonsil Hypertrophy

Clinical and Mechanism Study of Modified Tonsil Cauterization in the Treatment of Obstructive Sleep Apnea Hypopnea Syndrome with Tonsil Hypertrophy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047939
Enrollment
Unknown
Registered
2021-06-28
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-03-07

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

Conditions

Obstructive sleep apnea hypopnea syndrome

Interventions

Experimental group:Tonsil cauterization
Control group:Conventional treatment

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for obstructive sleep apnea hypopnea syndrome (OSAHS); 2. The subject's tonsil hypertrophy (tonsil >= 2° enlargement); 3. Aged 5-65 years (5-17 years old for children group, 18-65 years old for adult group); 4. All subjects are subjectively unwilling to accept or unable to accept non-invasive positive pressure ventilation treatment, oral appliance and surgical treatment due to objective reasons (such as poor economic conditions, facial skin irritation, nasal congestion, runny nose, increased intraocular pressure, abdominal distension, claustrophobia, etc.); 5. The patient or the guardian of the child has informed consent, and the subjects can cooperate and agree to participate in the research.

Exclusion criteria

Exclusion criteria: 1. Those with obvious abnormal blood routine and coagulation function; 2. Patients with severe abnormal upper airway anatomical structure except tonsillar hypertrophy; 3. Patients with history of pharyngeal reconstruction surgery, hypothyroidism, vocal cord paralysis, acromegaly and other special causes of sleep-disordered breathing, as well as the abuse of psychotropic drugs, long-term alcohol abuse, etc., which seriously affect the test results; 4. Pregnant, lactating women or women who intend to become pregnant; 5. Patients with mental disorders, severe cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, or tumors.

Design outcomes

Primary

MeasureTime frame
Symptoms and signs score;

Secondary

MeasureTime frame
Blood routine examination;Sleep monitoring;Epworth Sleepiness Scale;Childhood OSAHS disease-specific quality of life questionnaire;Immune factors;C-reactive protein;

Countries

China

Contacts

Public ContactChen Caifeng

Guangdong Provincial Hospital of Traditional Chinese Medicine

phoenixccf@126.com+86 18922115885

Outcome results

None listed

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