Ongoing Clinical Trials for Poor Quality Sleep
Currently, there is 1 ongoing clinical trial exploring treatments related to poor quality sleep. This trial is being conducted in Germany and focuses on patients with unresponsive wakefulness syndrome, a condition that severely affects sleep-wake cycles and consciousness. The study is investigating the medication Amantadine to improve alertness and responsiveness in intensive care patients.
Clinical trial locations
Study on Amantadine Hemisulfate for Patients with Unresponsive Wakefulness Syndrome in Intensive and Intermediate Care Units
This clinical trial is investigating the use of Amantadine Hemisulfate, delivered as Amantadin-ratiopharm® 200 mg Infusion Solution, in patients experiencing unresponsive wakefulness syndrome. This condition occurs when a person is awake but shows no signs of awareness of themselves or their surroundings, often following severe brain injury. The study takes place in intensive and intermediate care units in Germany and lasts for five days.
Main inclusion criteria:
- The patient or their legal representative must sign a document agreeing to participate in the study
- Women of childbearing potential must have a negative pregnancy test before starting treatment
- Patients must have reduced consciousness for at least 72 hours, with a Glasgow Coma Scale score of less than 8, which measures how awake and responsive a person is
- Brain activity tests (EEG) and heart activity tests (ECG) must show no unusual results
- Both men and women can participate
Main exclusion criteria:
- Patients with allergies or bad reactions to Amantadine
- Individuals with severe kidney problems or severe liver disease
- Patients with a history of seizures, which are sudden, uncontrolled electrical disturbances in the brain
- Pregnant or breastfeeding women
- Individuals currently participating in another clinical trial
- Patients with a history of drug or alcohol abuse
- Anyone with mental health conditions that might interfere with following study instructions
- Patients who have had recent major surgery
- Individuals with certain heart conditions
Focus and goal of the trial:
The main goal of this study is to assess whether Amantadine can improve alertness and responsiveness in patients with severely reduced consciousness. The medication is given through an infusion directly into the bloodstream over five days. Researchers will measure changes in the patients’ level of consciousness using the Glasgow Coma Scale, with a patient considered a responder if their score improves by at least 3 points.
The study also monitors patients using several other assessment tools, including the Richmond Agitation-Sedation Scale, the Full Outline of UnResponsiveness Score, the Coma Recovery Scale Revised, and the Montreal Cognitive Assessment. These tools help doctors get a comprehensive view of any improvements in the patients’ responsiveness and cognitive function. Additional evaluations include brain activity tests, survival rates, and clinical improvement after 90 days.
Investigational drug:
The medication being tested is Amantadine, a drug that influences neurotransmitter activity in the brain, particularly affecting dopamine release and reuptake. It is being studied for its potential to enhance alertness and responsiveness in patients with unresponsive wakefulness syndrome. Amantadine is classified as an antiviral and antiparkinsonian agent and is being explored in this trial for its ability to improve vigilance and consciousness levels.
Summary
Currently, there is one clinical trial addressing issues related to consciousness and wakefulness that may impact sleep quality. This trial is located in Germany and focuses specifically on patients in intensive and intermediate care units who are experiencing unresponsive wakefulness syndrome. The study is investigating Amantadine, a medication that works on brain chemistry by affecting dopamine activity, to determine if it can improve patients’ levels of alertness and responsiveness. The trial uses multiple assessment scales to carefully measure any improvements in consciousness over a five-day treatment period, with follow-up evaluations extending to 90 days after treatment.