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Efficacy of Tizanidine (0.1 mg/Kg/HS) Versus Zolpidem 10 mg HS in Primary Insomnia: Double Blind Randomized Controlled Trial
The study's primary objective is to evaluate the effectiveness of Tinazidine compared to Zolpidem in enhancing sleep quality, with secondary objectives including the assessment of adverse effects, safety profile, and patient tolerance with each treatment. The trial will be conducted as a double-blind RCT, with participants randomly assigned to receive either Tinazidine (0.1 mg/Kg/HS) or Zolpidem 10 mg HS, for 12 weeks. Eligible participants, aged 18-60 years, diagnosed with primary insomnia as per DSM-5 criteria, will be recruited from an outpatient sleep clinic affiliated with Al-Masara Hospital. Data on sleep quality, and side effects, will be collected using the Sleep Pittsburgh Sleep Quality Index (PSQI), Clinical Global Impression (CGI), sleep diaries, actigraphy, polysomnography, and regular clinical interview though OPD follow-up visits. The primary outcome considered was the mean global PSQI score before and after the treatment. The primary outcome will be measured four times (baseline, 4 weeks, 8 weeks, and 12 weeks), We considered an attrition rate (dropout/lost follow-up) of 10%. Therefore, the sample size is 90 subjects (45 in each group). Group comparisons for mean scores will be conducted using independent samples t-tests, and within-group comparisons will be assessed using paired samples t-tests. Changes in sleep quality over time between treatment groups will be evaluated using repeated measures ANOVA. Associations between categorical variables will be examined using Chi-square tests (including Fisher's exact or Likelihood ratio tests as appropriate). Statistical significance will be considered for p-values less than 0.05. All analyses will be performed using IBM SPSS Statistics (Version 29.0). The findings of this study seek to elucidate the comparative efficacy and safety profiles of Tizanidine and Zolpidem in treating primary insomnia. The study aims to offer insights into the effectiveness of Tizanidine versus Zolpidem in improving sleep quality among patients with primary insomnia. Through the evaluation of efficacy, adverse effects, and safety profiles. This study aims to inform clinicians and healthcare practitioners about the optimal treatment choices for individuals with primary insomnia.
Details
| Lead sponsor | Sultan Qaboos University |
|---|---|
| Phase | Phase 4 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 90 |
| Start date | 2024-09 |
| Completion | 2026-12 |
Conditions
- Depressive Disorder, Major
Interventions
- Tizanidine Hcl 4Mg Tab
- Zolpidem Tartrate 10 mg
Primary outcomes
- Pittsburgh Sleep Quality Index — Baseline, 4 weeks, 8 weeks, 12 weeks
Total Items: The PSQI contains a total of 24 questions. Range of Component Scores: Each component score ranges from 0 to 3 points. A score of 0 indicates no difficulty. A score of 3 indicates severe difficulty. Global PSQI Score: The seven component scores are summed to yield one "global" score. Range: The global score ranges from 0 to 21 points. A global score of 0 suggests no difficulty in any areas. A global score of 21 suggests severe difficulties in all areas. Interpretation of the Global Score: The global PSQI score is used to evaluate an individual's sleep quality. A global score greater than 5 often indicates significant sleep disturbances or poor sleep quality.