BridgeMD
Effect of NAL in participants with sleep disorders
EU CTIS ID: 2023-508445-40-00
What this study is testing
The objective of the study is to assess if Nacystelyn (NAL) Dry-Powder Inhaler (DPI) can be beneficial in the treatment of obstructive sleep apnea (OSA)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- Clinically significant craniofacial malformation.
- Participant who had a previous surgery for OSA within 4 weeks before screening.
- Participant with compromised mucociliary function (e.g. bronchiectasis).
- A significant infection of upper respiratory airways requiring medical treatment in the past 30 days.
- 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.
See the full eligibility criteria
- 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.
- Clinically significant craniofacial malformation.
- Participant who had a previous surgery for OSA within 4 weeks before screening.
- Participant with compromised mucociliary function (e.g. bronchiectasis).
- A significant infection of upper respiratory airways requiring medical treatment in the past 30 days.
- 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)
- Participants showing bronchial hyperresponsiveness to inhaled mannitol
- Participant presenting another clinically significant concomitant disease states that would interfere with the patient’s participation in the study or confound study interpretation.
- Participants presenting a hypersensitivity to the active substance (acetylcysteine), other chemically similar substances (e.g. carbocisteine or erdosteine) or to the excipient mannitol.
- Use of antitussives.
- Drug or alcohol abuse.
- Participant with inability to use a smartphone or impossibility to shave the beard
- Women who are pregnant or nursing.
- Clinically significant unstable cardiac disease and individuals presenting heart failure with an ejection fraction inferior to 40%.
- Participants presenting COPD (Tiffeneau index (FEV1/FVC) <0.7) or asthma.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.