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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating four different isotonic and hypertonic seawater-based nasal sprays in real-life settings for their effectiveness, safety, usage, tolerance, and user satisfaction. The study focuses on infants, children, adults, and pregnant or breastfeeding women who have acute or chronic sinonasal conditions such as upper respiratory tract infections, allergic rhinitis, chronic rhinosinusitis, bronchiolitis, COVID-19, and post-surgery nasal issues. The investigation aims to understand how these devices perform when used as intended across various patient groups. Participants will use one of four CE-marked nasal spray devices according to their specific indications and target populations. The sprays include Respimer Hygiene-Prevention for babies, kids, and adults, Respimer Decongestion for babies from two months old and older, and Phytosun arms Hypertonic nasal wash for children six years and older and adults. Usage instructions vary by product, ranging from 1 to 6 sprays per nostril daily, with different frequencies for treatment and prevention purposes. The study period covers up to three months to assess both short-term and longer-term effects. During the study, participants or their parents will complete online questionnaires and follow healthcare providers advice on nasal wash techniques. Researchers will monitor nasal symptom changes, including intensity and frequency, improvement in nasal breathing, quality of life, and satisfaction with the sprays. Effectiveness will be evaluated from day 0 to day 5 for acute conditions and up to day 14 for chronic issues, extending to three months for seasonal symptom management. Safety, tolerance, and usage patterns will also be recorded throughout the study.
Actively Recruiting
Researchers are investigating the use of a hypnotherapy method called E2R to manage chronic insomnia in primary care settings. Chronic insomnia is commonly treated with hypnotic drugs in France despite their risks, while cognitive-behavioral therapy is recommended but not widely available. This study aims to compare the effectiveness of E2R hypnotherapy against standard care without hypnosis in patients with chronic insomnia. Participants will be randomly assigned to one of two groups. One group will receive standard care from their general practitioner, which may include medications or psychotherapy but excludes hypnosis. The other group will undergo four 30-minute hypnotherapy sessions using the E2R method over six weeks, with additional practice of self-hypnosis. Both groups will have follow-up visits at 3 and 6 months after starting the study. During the study, patients will complete questionnaires assessing insomnia severity and sleep quality, record their use of psychotropic medications, and note any events affecting sleep. The research team will also monitor for neuropsychiatric side effects. These assessments occur at baseline, 3 months, and 6 months, with the main outcome measured by the Insomnia Severity Index at 6 months. Participation will last at least 6 months from enrollment.