protocolSection identificationModule nctId: NCT06278077, orgStudyIdInfo id: C2104, secondaryIdInfos id: 2022-003565-38, type: EUDRACT_NUMBER, briefTitle: Neurexan - a Clinical Trial in Short-Term Insomnia Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-04, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Biologische Heilmittel Heel GmbH, class: INDUSTRY, descriptionModule briefSummary: This clinical study aims to understand the effects of a medication called Neurexan on sleep patterns and stress in people with short-term insomnia. The study involves comparing Neurexan to a placebo - a tablet that looks like Neurexan but lacks active ingredients. The main goal of the study is to determine if Neurexan can enhance sleep efficiency in those with short-term insomnia. Sleep efficiency, which is the proportion of time spent asleep in relation to total time in bed, including attempts to fall asleep, will be assessed through Polysomnography (PSG). PSG examines various sleep characteristics such as brain activity, muscle and heart activity, and breathing.Participants will take either Neurexan or the placebo for 14 days. Sleep efficiency will be evaluated using PSG before and after the treatment period. Additionally, sleep quality-related factors will be investigated using PSG data, sleep diaries, and participant-completed questionnaires.The study will also investigate Neurexan's impact on stress levels. This will be assessed using the Cold Pressor Test, which measures stress through having the participant immerse their hand into ice water, and measuring changes in blood pressure and heart rate, both indicators of stress. In addition, blood and saliva samples collected before and after treatment with Neurexan or placebo, will be analyzed for stress-related hormones such as cortisol. Patient questionnaires and Electroencephalography (EEG), a non-invasive brain activity recording, will further assess stress symptoms.Researchers will analyze data related to sleep efficiency, sleep quality, and stress symptoms. By comparing outcomes before and after Neurexan or placebo treatment, the study aims to detect improvements in these areas. Positive results with Neurexan but not with the placebo would provide robust evidence for Neurexan's efficacy in addressing sleep and stress management issues. This study contributes valuable insights into Neurexan's potential benefits for individuals with short-term insomnia., conditionsModule conditions: Insomnia, conditions: Stress Reaction, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, double-blind, active- and placebo-controlled confirmatory clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All involved personnel at the investigational site, the Sponsor (except production unit) and the CRO (except independent biostatistician for performing the randomization) will be blinded during the trial. The Investigator keeps the sealed treatment code envelopes throughout the course of the trial for the individual patients and must not break the code without a valid reason (e.g., in case of emergency)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Neurexan, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline in Sleep Efficiency., secondaryOutcomes measure: Change from baseline in sleep pattern characterized by Number of Awakenings., secondaryOutcomes measure: Change from baseline in daytime performance assessed by Epworth Sleepiness Scale patient questionnaire., secondaryOutcomes measure: Ecological Momentary Assessments - continuous daily stress assessment., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jena University Hospital, Department of Psychiatry & Psychotherapy, status: RECRUITING, city: Jena, state: Thuringia, zip: 07743, country: Germany, contacts name: Martin Walter, MD, role: CONTACT, phone: +49 (0)3641 9390101, email: Martin.Walter@med.uni-jena.de, geoPoint lat: 50.92878, lon: 11.5899, hasResults: False