Study of Nacystelyn for Patients with Obstructive Sleep Apnea

What is this study about?

This clinical study focuses on examining the effects of a medication called Nacystelyn (also referred to as NAL) on patients suffering from a condition known as obstructive sleep apnea. This condition involves repeated episodes where a person’s breathing stops or becomes very shallow during sleep. The study will assess whether using Nacystelyn in the form of a dry-powder inhaler can help treat obstructive sleep apnea.

Nacystelyn will be compared to a placebo across different groups of participants. The medication is administered through an inhaler, which is a device that delivers medicine directly to the lungs when the patient breathes in. The goal of the study is to determine if Nacystelyn can effectively improve symptoms in individuals with obstructive sleep apnea over a treatment period of six weeks.

Participants in the study will receive either the Nacystelyn inhalation powder contained in hard capsules or a placebo. It aims to provide more understanding of the effectiveness and safety of this treatment in improving the sleep quality and overall health of those affected by this sleep disorder.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose and procedures. An informed consent form must be signed to confirm understanding and agreement to participate.

2 initial assessment

An initial assessment will be conducted to establish baseline measurements. This includes evaluating the apnea-hypopnea index (AHI), which measures the severity of sleep apnea.

3 medication administration

Participants will be randomly assigned to receive either the Nacystelyn (NAL) inhalation powder or a placebo. The medication is administered via inhalation using a dry-powder inhaler.

The dosage and frequency of administration will be specified by the study protocol, and participants will be instructed on how to use the inhaler correctly.

4 treatment period

The treatment period lasts for 6 weeks. During this time, participants will continue to use the inhaler as directed and maintain a record of any changes in symptoms or side effects.

5 follow-up assessments

Throughout the 6-week treatment period, follow-up assessments will be conducted to monitor changes in the apnea-hypopnea index (AHI) and other related measures.

These assessments will help determine the effectiveness of the treatment in reducing symptoms of obstructive sleep apnea.

6 final evaluation

At the end of the 6-week period, a final evaluation will be conducted to assess the overall impact of the treatment on sleep apnea symptoms.

This includes measuring changes in the apnea-hypopnea index (AHI) and other secondary outcomes such as oxygen levels and sleep quality.

Who Can Join the Study?

Adult individual with obstructive sleep apnea, a condition where breathing stops and starts during sleep.
Apnea-hypopnoea index (AHI) between 15 and 30 per hour. This index measures the severity of sleep apnea based on the number of pauses in breathing per hour of sleep.
Individual who has not used CPAP (Continuous Positive Airway Pressure) or has not been treated with CPAP for at least two months. CPAP is a common treatment for sleep apnea.
Oxygen desaturation index of 10 or more. This index measures how often the level of oxygen in the blood drops during sleep.
BMI (Body Mass Index) between 18 and 35.0 kg/m², inclusive. BMI is a measure of body fat based on height and weight.
If a woman of childbearing potential, the individual must agree to use the specified contraception methods. If female and not able to have children, the individual must be either postmenopausal (age 55 or older with no periods for 12 or more months without another medical reason) or have had surgery to remove the ovaries, fallopian tubes, or uterus.
Individual voluntarily agrees to participate in this clinical trial and signs an approved informed consent before any screening procedures.
Individual must be able to understand the nature of the clinical trial and have the opportunity to ask any questions.

Who Cannot Join the Study?

Individuals who do not have obstructive sleep apnea cannot participate. Obstructive sleep apnea is a condition where breathing stops and starts during sleep due to blocked airways.
Participants must be within a specific age range, which is not specified here.
Both males and females are eligible, so gender is not a reason for exclusion.
People who are considered part of a vulnerable population may be excluded. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country	Status
Pneumocare	Namur	Belgium
HUmani	Montigny-Le-Tilleul	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.04.2024
France	Not recruiting	01.04.2024

Trial locations

Investigated drugs:

Nacystelyn

Nacystelyn (NAL) Dry-Powder Inhaler (DPI) is being studied to see if it can help people with obstructive sleep apnea (OSA). This medication is inhaled as a dry powder, and the trial aims to find out if it can improve breathing during sleep for those with OSA.

Obstructive Sleep Apnea – This condition is characterized by repeated episodes of partial or complete blockage of the upper airway during sleep. These blockages lead to reduced or completely stopped airflow, causing breathing pauses that can last from a few seconds to minutes. As a result, the person may experience disrupted sleep and reduced oxygen levels in the blood. Common symptoms include loud snoring, gasping for air during sleep, and excessive daytime sleepiness. The condition can affect anyone but is more common in older adults and those with obesity. Over time, it can lead to complications if not managed properly.

Trial ID:

2023-508445-40-00

Protocol code:

NAL-II-23-1

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Nacystelyn for Patients with Obstructive Sleep Apnea

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