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Efficacy of high dose N-acetylcysteine on Obstructive Sleep Apnea Symptom (OSAS) and the comorbidity: A Prospective multicenter, randomized, double-blind, placebo-controlled study

Efficacy of high dose N-acetylcysteine on Obstructive Sleep Apnea Symptom (OSAS) and the comorbidity: A Prospective multicenter, randomized, double-blind, placebo-controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004578
Enrollment
Unknown
Registered
2014-04-25
Start date
2014-05-26
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Obstructive Sleep Apnea Symptom

Interventions

A:N-acetylcysteine 1200mg (600mg, twice daily)

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients able to provide written informed consent and to fulfil study request; 2. Outpatients, male or female, aged between 30 and 70 years (include), smoking or non-smoking; 3. Patients with a clinical diagnosis of moderate to severe OSASand not willing to accept operation, CPAP or oral appliance(OA) treatment; (1) Moderate: AHI 15-30Lowest SaO2 80-85%; (2) Severe: AHI > 30; (3) Lowest SaO2 < 80%.

Exclusion criteria

Exclusion criteria: 1. Patients with a diagnosis of COPD, bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, pneumonia, bronchial pneumonia, bronchiectasis, lung cancer or lung metastases, other progressively fatal disease; 2. FEV1/FVC 1.5×ULN)or renal function (Cr> 1.0×ULN). hematopoietic disorder, bleeding tendency or hemorrhagic disease; 4. Patients requiring mechanical airway management, long-term oxygen therapy (12 h or more per day) or respiratory rehabilitation; 5. Hospitalized patients and patients from institutional care facilities; 6. Immuno-compromised patients, HIV positive or patients on long term treatment with corticosteroids or immunosuppressive agents; 7. Patients with suspected or known hypersensitivity to the study product or to any of its excipients (such as for sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency); 8. Patients known to have conditions affecting study drug absorption or history of peptic ulcer; 9. Pregnant or lactating women, or in post-menopause for less than 1 year; 10. Patients presenting poor reliability and poor compliance (e.g. history of alcohol or drug abuse, bad mental conditions); 11. Patients who have received any other investigational drug within 3 months prior to study entry; 12. Unsuitable for the study for every other reason, in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
AHI;Lowest SaO2;new-onset cardiovascular and cerebrovascular event;

Secondary

MeasureTime frame
SIT90;Epworth sleepiness scale;blood pressure;blood glucose;Blood Lipid;CRP;New Diagnosed hypertension,coronary heart disease,;percentage of slow wave sleep;arousal index;

Countries

China

Contacts

Public ContactBaoyuan Chen

Tianjin Medical University General Hospital

13820413581@126.com+86 13820413581

Outcome results

None listed

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