Evaluation of the effectiveness and safety of treatment on insomnia patients converted to Dimdazenil because not satisfied with the treatment of non benzodiazepine sedatives and hypnotics
- Conditions
- insomnia
- Registration Number
- ChiCTR2400089017
- Lead Sponsor
- Shanghai Mental Health Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
To be eligible to participate in this study, all of the following selection criteria must be met:<br>1) Age = 18 and = 65 years old, gender not limited;<br>2) Take zolpidem, zopiclone, and dexzopiclone at least 3 nights a week within 2 weeks prior to the start of conversion therapy<br>Treatment with either Long or Zaleplon (limited to one), and dissatisfaction with treatment efficacy or safety (baseline)<br>Insomnia patients with overall satisfaction<4 and hope to switch to other medication treatments;<br>3) Intending to receive treatment with Dexmedetomidine;<br>4) Can ensure at least 7 hours of sleep time conditions;<br>5) Ability to read and fill out sleep diaries;<br>6) Voluntarily provide written informed consent.
Those who meet any of the following exclusion criteria are not eligible to participate in this study:<br>1) Contraindications for the use of Dedasinib include allergies to any excipients of Dedasinib and severe obstructive symptoms<br>Sleep apnea (OSA), respiratory dysfunction, or myasthenia gravis;<br>2) Simultaneous use of two or more benzodiazepine receptor agonists within 2 weeks prior to the start of conversion therapy<br>Therapy;<br>3) Used within 7 days prior to enrollment or within less than 5 drug half lives, except for two drugs other than benzodiazepines<br>Two or more drugs or health supplements that regulate sleep function or affect sleep;<br>4) Non pharmacological interventions for insomnia, such as cognitive-behavioral therapy, should be initiated within 7 days prior to the start of conversion therapy<br>Physical therapy, etc.);<br>5) Pregnant and lactating women;<br>6) Researchers believe that other situations are not suitable for participating in this clinical study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients who are satisfied with the overall drug treatment after 14 days of treatment with Dimdazenil (Likert -7-point comprehensive satisfaction score = 5);
- Secondary Outcome Measures
Name Time Method sTST;sSL;sSE;ISI;Changes in daytime function (Insomnia Severity Index Scale ISI: 5-7 items) scores compared to baseline after 14 days of treatment with Dimdazenil;Changes in Flinders Fatigue Scale scores between baseline and daytime fatigue levels after 14 days of treatment with Dimdazenil;Changes in daytime sleepiness (Epworth Sleepiness Scale) scores compared to baseline after 14 days of treatment with Dimdazenil;Incidence of adverse events during treatment with Dimdazenil;