nctId: NCT06300684 id: SBS-2022-0085 briefTitle: Exploring CBTi's Dual Effect on Sleep, Diet, & Chrononutrition overallStatus: RECRUITING date: 2022-11-11 date: 2024-12 date: 2025-01 date: 2024-03-08 date: 2024-03-12 name: American University of Beirut Medical Center class: OTHER briefSummary: This study aims to investigate the effects of Cognitive Behavioral Therapy for Insomnia (CBTi) on both sleep patterns and dietary habits in Lebanese adults with insomnia. Sleep patterns and dietary habits are intricately linked, with dysregulated sleep associated with poor diet quality and increased snacking. Conversely, the types of nutrients consumed can affect hormonal balance and circadian rhythm. Insomnia and obesity are interrelated public health concerns, with CBTi showing efficacy in improving sleep. This study will recruit participants with insomnia and randomly assign them to receive either CBTi or basic sleep hygiene education. Baseline assessments will include validated questionnaires about insomnia, dietary habits, and physical activity and a 7-day 24-hour diet recall sheets, as well as actigraphy for sleep parameters, and physical activity assessments. The intervention will last for four weeks, with post-intervention assessments conducted similarly to baseline. conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This parallel-design interventional study randomly assigns participants to receive either Cognitive Behavioral Therapy for Insomnia (CBTi) or basic sleep hygiene education over four weeks. CBTi aims to enhance sleep quality, while the control group receives sleep hygiene education. Pre- and post-intervention assessments will measure sleep parameters and dietary habits, comparing outcomes between groups. Randomization ensures unbiased assignment. Statistical analysis evaluates CBTi's effectiveness in improving sleep patterns and diet, exploring the potential indirect impact of improved sleep on diet. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will be blinded to the specific type of intervention they will receive, whether it is Cognitive Behavioral Therapy for Insomnia (CBTi) or basic sleep hygiene education. whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Cognitive Behavioral Therapy for Insomnia (CBT-i) measure: Change in Bed Time measure: Change in Get Up Time measure: Change in Time in Bed measure: Change in Sleep Onset Latency (in minutes). measure: Change in Sleep Efficiency measure: Change in Wake After Sleep Onset measure: Change in Late-Night Eating Occasions number measure: Change in Eating Window Duration and Fasting Window Duration measure: Change in Number of Meals sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lebanese American University status: ACTIVE_NOT_RECRUITING city: Jbaïl state: Keserwan-Jbeil Governorate zip: 1102-2801 country: Lebanon lat: 34.12111 lon: 35.64806 facility: American University of Beirut Medical Center status: RECRUITING city: Beirut zip: 1100 country: Lebanon name: Chadi Antoun, MD role: CONTACT phone: +961 81 524 015 email: CA116@aub.edu.lb name: Farid Talih, MD role: PRINCIPAL_INVESTIGATOR name: Chadi Antoun, MD role: SUB_INVESTIGATOR name: Ismat Annan, MSc role: SUB_INVESTIGATOR lat: 33.88894 lon: 35.49442 hasResults: False