Effect of NAL in participants with sleep disorders

Who can take part

• Adult individual with obstructive sleep apnea
• Apnea-hypopnoea index (AHI) ≥15/h and <30/h
• Individual naïve to CPAP or not treated by CPAP for at least two months
• Oxygen desaturation index ≥10
• BMI between 18 and 35.0 kg/m2, inclusive
• If a woman of childbearing potential (WOCBP), the individual must agree to practice the protocol specified contraception. If female and of non-childbearing potential, the individual must be either postmenopausal (defined as age ≥ 55 years with no menses for 12 or more months without an alternative medical cause) or permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
• Individual voluntarily agrees to participate in this clinical trial and signs an approved informed consent prior to performing any of the Screening Visit procedures
• Individual must be able to understand the nature of the clinical trial and must have the opportunity to have any questions answered

Who cannot take part

• Participant who had a previous surgery for OSA within 4 weeks before screening
• Use of steroidal and non-steroidal anti-inflammatory drugs, antioxidants or other medications that lower oxidative stress
• Use of cardiovascular medications, not stabilized for at least 3 months
• Use of drugs that impair sleep (hypnotics, sedatives, anxiolytics, melatonin, morphinics and derivatives which may influence sleep, central nervous stimulants)
• Participant presenting another clinically significant concomitant disease states that would interfere with the patient’s participation in the study or confound study interpretation
• Drug or alcohol abuse
• A significant infection of upper respiratory airways requiring medical treatment in the past 30 days
• Participants presenting a hypersensitivity to the active substance (acetylcysteine), other chemically similar substances (e.g. carbocisteine or erdosteine) or to the excipient mannitol
• Clinically significant unstable cardiac disease and individuals presenting heart failure with an ejection fraction inferior to 40%
• Clinically significant craniofacial malformation
• Participant with compromised mucociliary function (e.g. bronchiectasis)
• Participants showing bronchial hyperresponsiveness to inhaled mannitol
• Use of antitussives
• Participant with inability to use a smartphone or impossibility to shave the beard
• Women who are pregnant or nursing
• Participants presenting COPD (Tiffeneau index (FEV1/FVC) <0.7) or asthma