InsomniaNCT06300684
Exploring CBTi's Dual Effect on Sleep, Diet, & Chrononutrition
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-i) in people with Insomnia, run by American University of Beirut Medical Center at 2 sites in Lebanon.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBT-i)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesLebanon
- Study dates
- 11 Nov 2022to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English literate adult men and women participants aged 18 to 65 years with a complaint of insomnia.
Who cannot join
- Participants under 18 years old or above 65 years old.
- Participants with a known sleep disorder other than insomnia (sleep apnea, narcolepsy, or restless leg syndrome).
- Participants with a history of neurological disease including epilepsy/seizures and traumatic brain injury.
- Participants with active psychosis.
- Participants with hearing impairment.
Trial locations and contacts
2 sites in 1 country.
Lebanon2 sites, 1 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut, 1100
Chadi Antoun, MD, +961 81 524 015, CA116@aub.edu.lb
Farid Talih, MD
- Active, not recruiting
Lebanese American University
Byblos, Keserwan-Jbeil Governorate, 1102-2801
About this study
Official title: Sleep, Diet and Chrononutrition: Studying the Dual Effect of Cognitive Behavioral Therapy for Insomnia (CBTi) on Sleep and Dietary Habits
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.
Read the detailed description
This study aims to investigate the dual effect of Cognitive Behavioral Therapy for Insomnia (CBTi) on both sleeping patterns and dietary habits in Lebanese adults with insomnia. Sleep patterns and dietary habits are known to be closely interconnected, with dysregulated sleep often associated with poor diet quality and increased snacking. Conversely, the types of nutrients consumed can influence hormonal balance and circadian rhythm, impacting overall sleep quality.
Participants meeting the criteria for insomnia will be recruited and randomly assigned to either the intervention group receiving CBTi or the control group receiving basic sleep hygiene education. Baseline assessments will include comprehensive sleep evaluations using validated measures such as the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), and actigraphy for objective sleep parameters over 7 days prior to the intervention. Additionally, participants will complete 7-day 24-hour diet recall sheets to assess dietary habits. Physical activity assessments will also be conducted using the short form of the International Physical Activity Questionnaire (IPAQ). Emotional eating will also be assessed through an 18-item emotional eating questionnaire (EEQ).Patients will also complete the PHQ-4 (Patient Health Questionnaire 4) questionnaire for assessment of depression and anxiety.
During the intervention phase, participants in the treatment group will undergo Cognitive Behavioral Therapy for insomnia (CBTi) aimed at improving sleep quality, while those in the control group will receive placebo sleep intervention that consists of sleep hygiene tips. Post-intervention assessments will mirror baseline evaluations, allowing for the comparison of changes in sleep patterns and dietary habits between the two groups.
- Data collection involves the use of physical questionnaires and actigraphy devices. Paper-based data is securely stored in a locked drawer accessible only to research personnel. Actigraphy data is retrieved using specialized software, and any invalid or corrupt data prompts reassessment. Regular audits ensure data accuracy.
- Data entered into the registry undergoes thorough checks for consistency and adherence to predefined rules. Any discrepancies are flagged for further investigation and resolution.
- Validated measures such as the Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) are used alongside actigraphy to ensure accurate sleep data. Multiple sources are cross-referenced to enhance data accuracy.
- Variables include diet parameters (e.g., Late-Night Eating occasions, Eating Period) and sleep parameters (e.g., Bed Time, Total Sleep Time). Each variable is clearly defined with coding information and normal ranges where applicable.
- Recruitment occurs via snowball sampling and data collection through physical questionnaires. Data is digitized and tabulated for analysis using SPSS (Statistical Package for Social Sciences). Actigraphy data is analyzed using specialized software. Adverse events are reported and managed according to established procedures.
- Sample size assessment to specify the number of participants: A total of 40 participants will be recruited for the study to ensure adequate statistical power.
- Plan for missing data: Regular audits and checks allow early identification of missing data. Participants with missing data are prompted to provide the necessary information, or alternative participants are recruited.
- Statistical analysis plan: Statistical analyses include Wilcoxon signed-rank tests to assess pre-post intervention improvements, Spearman bivariate analysis to explore correlations between diet and sleep parameters, and Mann-Whitney tests to compare intervention and control group outcomes.
- Conditions
- Insomnia
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBT-i)
- Keywords
- Chrononutrition, Diet, Sleep, Circadian Rhythm
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBT-i)Behavioural
This intervention involves structured sessions aimed at addressing maladaptive sleep behaviors and promoting healthy sleep habits. Participants in this group will engage in cognitive restructuring, relaxation techniques, and sleep hygiene education to improve sleep quality and duration. The goal of CBTi is to modify behaviors and thoughts that contribute to insomnia, leading to more restful and consolidated sleep patterns.
| Study group | Role | What they receive |
|---|---|---|
| CBT-i | Experimental | The CBT-i group consists of participants who will receive Cognitive Behavioral Therapy for Insomnia (CBTi) over 4 weeks (1 session per week). This intervention involves structured sessions aimed at addressing maladaptive sleep behaviors and promoting healthy sleep habits. Participants in this group will engage in cognitive restructuring, relaxation techniques, and sleep hygiene education to improve sleep quality and duration. The goal of CBTi is to modify behaviors and thoughts that contribute to insomnia, leading to more restful and consolidated sleep patterns. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-i) |
| Sleep Hygiene | No intervention | The Sleep Hygiene group consists of participants who will not receive any specific therapeutic intervention. Instead, participants in this group will receive basic sleep hygiene education, which includes general recommendations and guidance on healthy sleep habits, which does not involve a structured therapeutic intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bed Time
Participants undergoing Cognitive Behavioral Therapy for Insomnia (CBTi) are expected to demonstrate significant change in Bed Time (in hours).
Measured: immediately after the intervention of 4 weeks duration
Change in Get Up Time
Participants undergoing CBTi are expected to demonstrate significant improvements in Get Up Time (in hours).
Measured: immediately after the intervention of 4 weeks duration
Change in Time in Bed
Participants undergoing CBTi are expected to demonstrate significant improvements in Time in Bed (in hours).
Measured: immediately after the intervention of 4 weeks duration
Change in Sleep Onset Latency (in minutes).
Participants undergoing CBTi are expected to demonstrate significant reductions in Sleep Onset Latency (in minutes).
Measured: immediately after the intervention of 4 weeks duration
Change in Sleep Efficiency
Participants undergoing CBTi are expected to demonstrate significant improvements in Sleep Efficiency (percentage).
Measured: immediately after the intervention of 4 weeks duration
Change in Wake After Sleep Onset
Participants undergoing CBTi are expected to demonstrate significant decreases in Wake After Sleep Onset (in minutes).
Measured: immediately after the intervention of 4 weeks duration
Change in Late-Night Eating Occasions number
Participants undergoing CBTi are anticipated to demonstrate a decrease in late-night eating occasions.
Measured: immediately after the intervention of 4 weeks duration
Change in Eating Window Duration and Fasting Window Duration
Participants undergoing CBTi are anticipated to exhibit a narrower and more restricted eating window in hours and consequently an increase in the nightly fasting period.
Measured: immediately after the intervention of 4 weeks duration
Change in Number of Meals
Participants undergoing CBTi are anticipated to experience alterations in the number of meals consumed.
Measured: immediately after the intervention of 4 weeks duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start11 Nov 2022
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farid Talih, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300684
- Sponsor's protocol ID
- SBS-2022-0085
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zuraikat FM, Wood RA, Barragan R, St-Onge MP. Sleep and Diet: Mounting Evidence of a Cyclical Relationship. Annu Rev Nutr. 2021 Oct 11;41:309-332. doi: 10.1146/annurev-nutr-120420-021719. Epub 2021 Aug 4.
PubMed 34348025Ferini-Strambi L, Auer R, Bjorvatn B, Castronovo V, Franco O, Gabutti L, Galbiati A, Hajak G, Khatami R, Kitajima T, McEvoy D, Nissen C, Perlis M, Pevernagie DA, Randerath W, Riemann D, Rizzo G, Van Someren E, Vgontzas A, Barazzoni F, Bassetti C; European Sleep Foundation. Insomnia disorder: clinical and research challenges for the 21st century. Eur J Neurol. 2021 Jul;28(7):2156-2167. doi: 10.1111/ene.14784. Epub 2021 Apr 9.
PubMed 33619858Buenaver LF, Townsend D, Ong JC. Delivering Cognitive Behavioral Therapy for Insomnia in the Real World: Considerations and Controversies. Sleep Med Clin. 2019 Jun;14(2):275-281. doi: 10.1016/j.jsmc.2019.01.008. Epub 2019 Mar 29.
PubMed 31029193Davidson JR, Dawson S, Krsmanovic A. Effectiveness of Group Cognitive Behavioral Therapy for Insomnia (CBT-I) in a Primary Care Setting. Behav Sleep Med. 2019 Mar-Apr;17(2):191-201. doi: 10.1080/15402002.2017.1318753. Epub 2017 May 2.
PubMed 28463015Siebern AT, Manber R. New developments in cognitive behavioral therapy as the first-line treatment of insomnia. Psychol Res Behav Manag. 2011;4:21-8. doi: 10.2147/PRBM.S10041. Epub 2011 Feb 25.
PubMed 22114532Duraccio KM, Zaugg K, Jensen CD. Effects of Sleep Restriction on Food-Related Inhibitory Control and Reward in Adolescents. J Pediatr Psychol. 2019 Jul 1;44(6):692-702. doi: 10.1093/jpepsy/jsz008.
PubMed 30861067Duraccio KM, Krietsch KN, Chardon ML, Van Dyk TR, Beebe DW. Poor sleep and adolescent obesity risk: a narrative review of potential mechanisms. Adolesc Health Med Ther. 2019 Sep 9;10:117-130. doi: 10.2147/AHMT.S219594. eCollection 2019.
PubMed 31572040Goldschmidt AB, Evans EW, Saletin JM, O'Sullivan K, Koren D, Engel SG, Haedt-Matt A. Naturalistic, multimethod exploratory study of sleep duration and quality as predictors of dysregulated eating in youth with overweight and obesity. Appetite. 2020 Mar 1;146:104521. doi: 10.1016/j.appet.2019.104521. Epub 2019 Nov 18.
PubMed 31751632Gupta K, Jansen EC, Campos H, Baylin A. Associations between sleep duration and Mediterranean diet score in Costa Rican adults. Appetite. 2022 Mar 1;170:105881. doi: 10.1016/j.appet.2021.105881. Epub 2021 Dec 21.
PubMed 34942284Zhao M, Tuo H, Wang S, Zhao L. The Effects of Dietary Nutrition on Sleep and Sleep Disorders. Mediators Inflamm. 2020 Jun 25;2020:3142874. doi: 10.1155/2020/3142874. eCollection 2020.
PubMed 32684833Galland L. Diet and inflammation. Nutr Clin Pract. 2010 Dec;25(6):634-40. doi: 10.1177/0884533610385703.
PubMed 21139128Ngo-Nkondjock RV, Yuntao Z, Adnan H, Adnan SM, Cheteu TMW, Li Y. The chronotype conjecture in the association between dietary carbohydrate intake and high-sensitivity C-reactive protein (hs-CRP): a cross-sectional study from NHANES 2015 data. Sleep Sci. 2021 Jan-Mar;14(1):3-10. doi: 10.5935/1984-0063.20200047.
PubMed 34104331Afaghi A, O'Connor H, Chow CM. High-glycemic-index carbohydrate meals shorten sleep onset. Am J Clin Nutr. 2007 Feb;85(2):426-30. doi: 10.1093/ajcn/85.2.426.
PubMed 17284739Du C, Almotawa J, Feldpausch CE, Folk SYL, Parag H, Tucker RM. Effects of macronutrient intake on sleep duration and quality: A systematic review. Nutr Diet. 2022 Feb;79(1):59-75. doi: 10.1111/1747-0080.12671. Epub 2021 Apr 19.
PubMed 33876534Campanini MZ, Guallar-Castillon P, Rodriguez-Artalejo F, Lopez-Garcia E. Mediterranean Diet and Changes in Sleep Duration and Indicators of Sleep Quality in Older Adults. Sleep. 2017 Mar 1;40(3). doi: 10.1093/sleep/zsw083.
PubMed 28364422
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Diet and Chrononutrition: Studying the Dual Effect of Cognitive Behavioral Therapy for Insomnia (CBTi) on Sleep and Dietary Habits
- ClinicalTrials.gov ID
- NCT06300684
- Acronym / sponsor ID
- SBS-2022-0085
- Conditions
- Insomnia
- Keywords
- Chrononutrition, Diet, Sleep, Circadian Rhythm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to investigate the dual effect of Cognitive Behavioral Therapy for Insomnia (CBTi) on both sleeping patterns and dietary habits in Lebanese adults with insomnia. Sleep patterns and dietary habits are known to be closely interconnected, with dysregulated sleep often associated with poor diet quality and increased snacking. Conversely, the types of nutrients consumed can influence hormonal balance and circadian rhythm, impacting overall sleep quality.
Participants meeting the criteria for insomnia will be recruited and randomly assigned to either the intervention group receiving CBTi or the control group receiving basic sleep hygiene education. Baseline assessments will include comprehensive sleep evaluations using validated measures such as the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), and actigraphy for objective sleep parameters over 7 days prior to the intervention. Additionally, participants will complete 7-day 24-hour diet recall sheets to assess dietary habits. Physical activity assessments will also be conducted using the short form of the International Physical Activity Questionnaire (IPAQ). Emotional eating will also be assessed through an 18-item emotional eating questionnaire (EEQ).Patients will also complete the PHQ-4 (Patient Health Questionnaire 4) questionnaire for assessment of depression and anxiety.
During the intervention phase, participants in the treatment group will undergo Cognitive Behavioral Therapy for insomnia (CBTi) aimed at improving sleep quality, while those in the control group will receive placebo sleep intervention that consists of sleep hygiene tips. Post-intervention assessments will mirror baseline evaluations, allowing for the comparison of changes in sleep patterns and dietary habits between the two groups.
- Data collection involves the use of physical questionnaires and actigraphy devices. Paper-based data is securely stored in a locked drawer accessible only to research personnel. Actigraphy data is retrieved using specialized software, and any invalid or corrupt data prompts reassessment. Regular audits ensure data accuracy.
- Data entered into the registry undergoes thorough checks for consistency and adherence to predefined rules. Any discrepancies are flagged for further investigation and resolution.
- Validated measures such as the Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) are used alongside actigraphy to ensure accurate sleep data. Multiple sources are cross-referenced to enhance data accuracy.
- Variables include diet parameters (e.g., Late-Night Eating occasions, Eating Period) and sleep parameters (e.g., Bed Time, Total Sleep Time). Each variable is clearly defined with coding information and normal ranges where applicable.
- Recruitment occurs via snowball sampling and data collection through physical questionnaires. Data is digitized and tabulated for analysis using SPSS (Statistical Package for Social Sciences). Actigraphy data is analyzed using specialized software. Adverse events are reported and managed according to established procedures.
- Sample size assessment to specify the number of participants: A total of 40 participants will be recruited for the study to ensure adequate statistical power.
- Plan for missing data: Regular audits and checks allow early identification of missing data. Participants with missing data are prompted to provide the necessary information, or alternative participants are recruited.
- Statistical analysis plan: Statistical analyses include Wilcoxon signed-rank tests to assess pre-post intervention improvements, Spearman bivariate analysis to explore correlations between diet and sleep parameters, and Mann-Whitney tests to compare intervention and control group outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CBT-i | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-i)The CBT-i group consists of participants who will receive Cognitive Behavioral Therapy for Insomnia (CBTi) over 4 weeks (1 session per week). This intervention involves structured sessions aimed at addressing maladaptive sleep behaviors and promoting healthy sleep habits. Participants in this group will engage in cognitive restructuring, relaxation techniques, and sleep hygiene education to improve sleep quality and duration. The goal of CBTi is to modify behaviors and thoughts that contribute to insomnia, leading to more restful and consolidated sleep patterns. |
| Sleep Hygiene | No intervention | –The Sleep Hygiene group consists of participants who will not receive any specific therapeutic intervention. Instead, participants in this group will receive basic sleep hygiene education, which includes general recommendations and guidance on healthy sleep habits, which does not involve a structured therapeutic intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English literate adult men and women participants aged 18 to 65 years with a complaint of insomnia.
Key exclusion criteria (5 listed)
- Participants under 18 years old or above 65 years old.
- Participants with a known sleep disorder other than insomnia (sleep apnea, narcolepsy, or restless leg syndrome).
- Participants with a history of neurological disease including epilepsy/seizures and traumatic brain injury.
- Participants with active psychosis.
- Participants with hearing impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-i)This intervention involves structured sessions aimed at addressing maladaptive sleep behaviors and promoting healthy sleep habits. Participants in this group will engage in cognitive restructuring, relaxation techniques, and sleep hygiene education to improve sleep quality and duration. The goal of CBTi is to modify behaviors and thoughts that contribute to insomnia, leading to more restful and consolidated sleep patterns. | Behavioural | CBT-i |
Primary outcome
Change in Bed Time
Time frame: immediately after the intervention of 4 weeks duration
Participants undergoing Cognitive Behavioral Therapy for Insomnia (CBTi) are expected to demonstrate significant change in Bed Time (in hours).
Change in Get Up Time
Time frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are expected to demonstrate significant improvements in Get Up Time (in hours).
Change in Time in Bed
Time frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are expected to demonstrate significant improvements in Time in Bed (in hours).
Change in Sleep Onset Latency (in minutes).
Time frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are expected to demonstrate significant reductions in Sleep Onset Latency (in minutes).
Change in Sleep Efficiency
Time frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are expected to demonstrate significant improvements in Sleep Efficiency (percentage).
Change in Wake After Sleep Onset
Time frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are expected to demonstrate significant decreases in Wake After Sleep Onset (in minutes).
Change in Late-Night Eating Occasions number
Time frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are anticipated to demonstrate a decrease in late-night eating occasions.
Change in Eating Window Duration and Fasting Window Duration
Time frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are anticipated to exhibit a narrower and more restricted eating window in hours and consequently an increase in the nightly fasting period.
Change in Number of Meals
Time frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are anticipated to experience alterations in the number of meals consumed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 34348025Zuraikat FM, Wood RA, Barragan R, St-Onge MP. Sleep and Diet: Mounting Evidence of a Cyclical Relationship. Annu Rev Nutr. 2021 Oct 11;41:309-332. doi: 10.1146/annurev-nutr-120420-021719. Epub 2021 Aug 4.
- Background: PubMed 33619858Ferini-Strambi L, Auer R, Bjorvatn B, Castronovo V, Franco O, Gabutti L, Galbiati A, Hajak G, Khatami R, Kitajima T, McEvoy D, Nissen C, Perlis M, Pevernagie DA, Randerath W, Riemann D, Rizzo G, Van Someren E, Vgontzas A, Barazzoni F, Bassetti C; European Sleep Foundation. Insomnia disorder: clinical and research challenges for the 21st century. Eur J Neurol. 2021 Jul;28(7):2156-2167. doi: 10.1111/ene.14784. Epub 2021 Apr 9.
- Background: PubMed 31029193Buenaver LF, Townsend D, Ong JC. Delivering Cognitive Behavioral Therapy for Insomnia in the Real World: Considerations and Controversies. Sleep Med Clin. 2019 Jun;14(2):275-281. doi: 10.1016/j.jsmc.2019.01.008. Epub 2019 Mar 29.
- Background: PubMed 28463015Davidson JR, Dawson S, Krsmanovic A. Effectiveness of Group Cognitive Behavioral Therapy for Insomnia (CBT-I) in a Primary Care Setting. Behav Sleep Med. 2019 Mar-Apr;17(2):191-201. doi: 10.1080/15402002.2017.1318753. Epub 2017 May 2.
- Background: PubMed 22114532Siebern AT, Manber R. New developments in cognitive behavioral therapy as the first-line treatment of insomnia. Psychol Res Behav Manag. 2011;4:21-8. doi: 10.2147/PRBM.S10041. Epub 2011 Feb 25.
- Background: PubMed 30861067Duraccio KM, Zaugg K, Jensen CD. Effects of Sleep Restriction on Food-Related Inhibitory Control and Reward in Adolescents. J Pediatr Psychol. 2019 Jul 1;44(6):692-702. doi: 10.1093/jpepsy/jsz008.
- Background: PubMed 31572040Duraccio KM, Krietsch KN, Chardon ML, Van Dyk TR, Beebe DW. Poor sleep and adolescent obesity risk: a narrative review of potential mechanisms. Adolesc Health Med Ther. 2019 Sep 9;10:117-130. doi: 10.2147/AHMT.S219594. eCollection 2019.
- Background: PubMed 31751632Goldschmidt AB, Evans EW, Saletin JM, O'Sullivan K, Koren D, Engel SG, Haedt-Matt A. Naturalistic, multimethod exploratory study of sleep duration and quality as predictors of dysregulated eating in youth with overweight and obesity. Appetite. 2020 Mar 1;146:104521. doi: 10.1016/j.appet.2019.104521. Epub 2019 Nov 18.
- Background: PubMed 34942284Gupta K, Jansen EC, Campos H, Baylin A. Associations between sleep duration and Mediterranean diet score in Costa Rican adults. Appetite. 2022 Mar 1;170:105881. doi: 10.1016/j.appet.2021.105881. Epub 2021 Dec 21.
- Background: PubMed 32684833Zhao M, Tuo H, Wang S, Zhao L. The Effects of Dietary Nutrition on Sleep and Sleep Disorders. Mediators Inflamm. 2020 Jun 25;2020:3142874. doi: 10.1155/2020/3142874. eCollection 2020.
- Background: PubMed 21139128Galland L. Diet and inflammation. Nutr Clin Pract. 2010 Dec;25(6):634-40. doi: 10.1177/0884533610385703.
- Background: PubMed 34104331Ngo-Nkondjock RV, Yuntao Z, Adnan H, Adnan SM, Cheteu TMW, Li Y. The chronotype conjecture in the association between dietary carbohydrate intake and high-sensitivity C-reactive protein (hs-CRP): a cross-sectional study from NHANES 2015 data. Sleep Sci. 2021 Jan-Mar;14(1):3-10. doi: 10.5935/1984-0063.20200047.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farid Talih, MD principal investigator
American University of Beirut Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-i) in people with Insomnia, run by American University of Beirut Medical Center at 2 sites in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chadi Antoun, MD (+961 81 524 015, ca116@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bed Time (time frame: immediately after the intervention of 4 weeks duration). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06300684, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.