protocolSection identificationModule nctId: NCT06300684, orgStudyIdInfo id: SBS-2022-0085, briefTitle: Exploring CBTi's Dual Effect on Sleep, Diet, & Chrononutrition, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-11, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: American University of Beirut Medical Center, class: OTHER, descriptionModule 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., conditionsModule conditions: Insomnia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo 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, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Behavioral Therapy for Insomnia (CBT-i), outcomesModule primaryOutcomes measure: Change in Bed Time, primaryOutcomes measure: Change in Get Up Time, primaryOutcomes measure: Change in Time in Bed, primaryOutcomes measure: Change in Sleep Onset Latency (in minutes)., primaryOutcomes measure: Change in Sleep Efficiency, primaryOutcomes measure: Change in Wake After Sleep Onset, primaryOutcomes measure: Change in Late-Night Eating Occasions number, primaryOutcomes measure: Change in Eating Window Duration and Fasting Window Duration, primaryOutcomes measure: Change in Number of Meals, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lebanese American University, status: ACTIVE_NOT_RECRUITING, city: Jbaïl, state: Keserwan-Jbeil Governorate, zip: 1102-2801, country: Lebanon, geoPoint lat: 34.12111, lon: 35.64806, locations facility: American University of Beirut Medical Center, status: RECRUITING, city: Beirut, zip: 1100, country: Lebanon, contacts name: Chadi Antoun, MD, role: CONTACT, phone: +961 81 524 015, email: CA116@aub.edu.lb, contacts name: Farid Talih, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Chadi Antoun, MD, role: SUB_INVESTIGATOR, contacts name: Ismat Annan, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 33.88894, lon: 35.49442, hasResults: False