#1 Clinical Trials Search in Europe

Study on Neurexan for Improving Sleep in Patients with Short-Term Insomnia

2 1 1

What is this study about?

This clinical trial is focused on studying the effects of a medication called Neurexan on individuals experiencing short-term insomnia. Short-term insomnia is a condition where people have trouble sleeping for a period of less than three months. The trial aims to see if Neurexan can help improve sleep efficiency, which means how well a person sleeps during the night. Neurexan is a tablet that contains natural ingredients like zincum isovalerianicum, coffea arabica, passiflora incarnata, and avena sativa. These ingredients are used in homeopathic medicine to help with sleep and stress.

Participants in the study will be given either Neurexan or a placebo, which looks like the medication but does not contain any active ingredients. The study will monitor how well participants sleep using a method called polysomnography, which records brain waves, oxygen levels, heart rate, and breathing during sleep. Additionally, participants will report their sleep patterns and daytime performance through questionnaires. The study will also look at stress response by measuring certain markers in the body.

The trial will take place over a period of time, with participants taking the medication daily. The goal is to determine if Neurexan can improve sleep and reduce stress in people with short-term insomnia. This study is exploratory, meaning it is designed to gather more information about how Neurexan works in improving sleep and managing stress. Participants will be closely monitored throughout the study to ensure their safety and to collect accurate data on the effects of the treatment.

1 initial visit

The trial begins with an initial visit where eligibility is confirmed. This includes checking for short-term insomnia as defined by specific criteria.

Participants must be between 18 and 65 years old, with a body mass index (BMI) between 18.5 and 29.9 kg/m².

2 baseline assessment

Participants undergo a baseline assessment to measure sleep efficiency using polysomnography, a test that records brain waves, oxygen levels, heart rate, and breathing during sleep.

Participants are required to report their habitual bedtime and time spent in bed.

3 treatment phase

Participants receive either Neurexan tablets or a placebo. Neurexan contains active substances such as zincum isovalerianicum and coffea arabica.

The medication is taken orally in tablet form. The dosage and frequency are determined by the study protocol.

4 follow-up visits

Participants attend follow-up visits to monitor changes in sleep efficiency and other sleep parameters.

These visits include further polysomnography tests and assessments of daytime performance and stress response.

5 final assessment

The trial concludes with a final assessment to evaluate the overall effects of the treatment on sleep efficiency and other related outcomes.

Participants complete sleep questionnaires and diaries to provide subjective feedback on their sleep patterns.

Who Can Join the Study?

  • The patient must have short-term insomnia as defined by the DSM-5 criteria, with symptoms lasting less than 3 months.
  • The patient should have moderate symptoms of short-term insomnia, with a score between 8 and 22 on the Insomnia Severity Index (ISI), present for at least one week but not longer than 3 months before the screening visit.
  • The patient should report a habitual bedtime between 9:00 PM and 1:00 AM, which is the time they usually try to sleep.
  • The patient should report spending 6 to 9 hours in bed each night, either sleeping or trying to sleep.
  • The patient must be 18 years or older, but not older than 65 years.
  • The patient must be legally competent, meaning they are able to make their own decisions.
  • The patient must have signed an informed consent, agreeing to participate in the study.
  • Females who can have children must agree to use highly effective or acceptable birth control methods during the trial. Highly effective methods include hormonal contraception, intrauterine devices, and others. Acceptable methods include condoms and other barrier methods.
  • The patient must have a Body Mass Index (BMI) between 18.5 and 29.9 kg/m² at the screening visit. BMI is a measure of body fat based on height and weight.
  • The patient must be able to use a digital device like a smartphone, tablet, or laptop.
  • The patient must be able to speak and read German.

Who Cannot Join the Study?

  • Patients with any other sleep disorders besides short-term insomnia cannot participate. This means if you have other sleep problems, you may not be eligible.
  • Individuals with serious medical conditions that could affect sleep or the study results are excluded. This means if you have a major health issue, you might not be able to join.
  • People who are currently taking medications that affect sleep are not allowed to participate. This means if you are on sleep-related medication, you may not qualify.
  • Participants who have a history of drug or alcohol abuse are excluded. This means if you have had problems with drugs or alcohol, you might not be eligible.
  • Women who are pregnant or breastfeeding cannot take part in the study. This means if you are expecting a baby or nursing, you may not be able to join.
  • Individuals who have participated in another clinical trial recently are not allowed. This means if you have been in a different study lately, you might not qualify.
  • People with known allergies to the study medication are excluded. This means if you are allergic to the treatment being tested, you cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
15.03.2023

Trial locations

Neurexan is a medication being studied for its potential to improve sleep efficiency in people with short-term insomnia. The trial aims to see if taking Neurexan daily can help patients sleep better, as measured by various methods like polysomnography, which records brain waves and other sleep-related data. The study also looks at how Neurexan might affect daytime performance and stress levels, using both scientific measurements and patient feedback.

Investigated diseases:

Short-Term Insomnia – Short-term insomnia is a sleep disorder characterized by difficulty falling asleep or staying asleep for a brief period, typically lasting a few days to a few weeks. It often occurs due to stress, changes in sleep environment, or disruptions in daily routine. Individuals with short-term insomnia may experience reduced sleep quality, leading to daytime fatigue, irritability, and difficulty concentrating. The condition usually resolves on its own once the underlying cause is addressed or the individual adapts to changes. It is distinct from chronic insomnia, which persists for a longer duration and may require more comprehensive management.

Trial ID:
2024-514391-41-00
Protocol code:
C2104
NCT ID:
NCT06278077
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study of tasimelteon compared to placebo for treating insomnia in children

    Recruiting

    3 1
    Investigated drugs:
    Germany Poland

  • Study of Light Therapy and Melatonin for Treatment of Major Depressive Episode with Insomnia

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France