protocolSection identificationModule nctId: NCT06303076, orgStudyIdInfo id: 134, briefTitle: Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Sultan Qaboos University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Depressive Disorder, Major, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Tizanidine Hcl 4Mg Tab, interventions name: Zolpidem Tartrate 10 mg, outcomesModule primaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Frequency and Severity of Side Effects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False