A clinical trial to study the effects of the drug, N-acetylcysteine in patients with obstructive sleep apnea

Investigation of the effect of add on N-acetylcysteine (NAC) and its correlation with oxidative stress and quality of life in patients with obstructive sleep apnea: A randomized, double blind, placebo-controlled, two-arm, proof of concept study - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099949

Enrollment

Registered

2025-12-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: G473- Sleep apnea

Interventions

Intervention1: N-acetylcysteine 600 mg: N-acetylcysteine 600 mg will be given at morning and night for 30 days Control Intervention1: Placebo: Glucose tablet identical in size and shape to N-acetylcys

Eligibility

Inclusion criteria

Inclusion criteria: Participants clinically diagnosed or polysomnography confirmed as Obstructive sleep apnea Participants aged 18-70 years of either gender Participants willing to participate and give informed consent for the study Consent to provide blood samples

Exclusion criteria

Exclusion criteria: Women who are pregnant, breastfeeding, or planning to become pregnant during the study period Participants with current alcohol consumption or use of psychotropic/antidepressant drugs Participants with active smoking (current smoker) Participants with central sleep apnea predominant Participants with active respiratory or ENT infection/exacerbation at screening (e.g., acute sinusitis, uncontrolled asthma/COPD) Participants with uncontrolled major medical illness that could increase risk or confound outcomes (e.g., unstable CAD, decompensated heart failure, advanced hepatic/renal failure, uncontrolled thyroid disease) Participants who are unable to provide informed consent or comply with study procedures.

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of add on N-acetylcysteine on amelioration of Obstructive sleep apnea by reducing inflammation and oxidative stressTimepoint: At baseline and 30 days	—

Secondary

Measure	Time frame
To assess the effect of add on N-acetylcysteine on quality of life in patients with obstructive sleep apnea. To evaluate the association between baseline EDC levels and oxidative stress biomarkers, to explore whether higher EDCs burden is linked to increased oxidative imbalance and predisposition to OSA. To evaluate the association between inflammatory markers (TNF, IL-6, Hs-CRP) and severity of obstructive sleep apnea. To evaluate the association between hormonal levels (Thyroid hormones/Vitamin D/Testosterone/estrogen) and the severity of obstructive sleep apnea. To evaluate the association between lipid profile and severity of obstructive sleep apnea. To evaluate the association between blood glucose levels and severity of obstructive sleep apnea. Timepoint: At baseline and 30 days	—

Measure

Time frame

To assess the effect of add on N-acetylcysteine on quality of life in patients with obstructive sleep apnea. To evaluate the association between baseline EDC levels and oxidative stress biomarkers, to explore whether higher EDCs burden is linked to increased oxidative imbalance and predisposition to OSA. To evaluate the association between inflammatory markers (TNF, IL-6, Hs-CRP) and severity of obstructive sleep apnea. To evaluate the association between hormonal levels (Thyroid hormones/Vitamin D/Testosterone/estrogen) and the severity of obstructive sleep apnea. To evaluate the association between lipid profile and severity of obstructive sleep apnea. To evaluate the association between blood glucose levels and severity of obstructive sleep apnea. Timepoint: At baseline and 30 days

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Countries

India

Contacts

Public ContactDr Jayadevan K

All India Institute of Medical Sciences, New Delhi

jagritiaiims2012@gmail.com9868394054

Outcome results

None listed

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