[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06684444":3,"trial-entities:NCT06684444":91,"trial-summary:NCT06684444":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":47,"secondary_outcomes":55,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":15,"eligibility_criteria":67,"std_ages":75,"locations":78,"central_contacts":87,"overall_officials":88,"references":89,"see_also_links":90},"NCT06684444","STUDY00001612","Evaluating Worksite Sleep Health Coaching in Firefighters: The Sleep Assistance for Firefighters Study","Assessing Clinical Effectiveness and Implementation of Worksite Sleep Health Coaching in Firefighters","ENROLLING_BY_INVITATION","2028-07","2026-07","2026-07-16","2024-10-21","University of Arizona","OTHER",false,"Insufficient sleep is a significant public health issue, particularly affecting shift workers like firefighters, nearly half of whom report short or poor-quality sleep, with 35-40% screening positive for sleep disorders. Cognitive Behavioral Therapy for Insomnia (CBTi) is a recommended and effective treatment, but access to such interventions remains low. This study will recruit 20 fire agencies in Arizona (400 firefighters) to test if a CBTi-informed intervention, including sleep health coaching and agency-wide promotion, improves sleep more effectively than usual care. The trial will also explore factors that influence successful implementation across agencies.","Insufficient sleep is a major public health crisis in the United States and worldwide, disproportionately affecting shift workers and other at-risk groups. Firefighters are one such group at heightened risk for disturbed sleep. Almost half of career firefighters report short sleep and poor sleep quality, and 35-40% of firefighters screen positive for a sleep disorder.\n\nEvidence-based sleep health interventions are available and highly effective in eliciting behavioral change. The American College of Physicians recommends Cognitive Behavioral Therapy for Insomnia (CBTi) as the first-line treatment for Insomnia Disorder, and substantial evidence supports the efficacy of this therapy with comorbid conditions, including shiftwork and obstructive sleep apnea. Unfortunately, access to CBT-informed sleep health interventions remains low. Workplace wellness programs could be one way to help more firefighters receive sleep intervention.\n\nThis study will recruit 20 fire agencies in Arizona (n = 400 career firefighters) to examine whether a CBTi-informed intervention is more effective than usual care in reducing sleep disturbances or improving multidimensional sleep health. The intervention will last one year and will include telephone-administered sleep health coaching to firefighters, sleep health promotion to the agency and agency leaders, and external\u002Finternal facilitation strategies for implementation. The trial will also examine which combinations of factors are associated with successful agency implementation of the intervention. All participating agencies will receive the intervention; however, some agencies will wait longer to receive the intervention than others.",[19,20,21,22],"Cognitive Behavioral Therapy","Sleep Initiation and Maintenance Disorders","Sleep Deprivation","Sleep Disorders, Intrinsic",[24,25,26,27,28],"CBTi","sleep deprivation","sleep disorders","firefighters","sleep health coaching","INTERVENTIONAL","PREVENTION",[32],"PHASE4",{"count":34,"type":35},400,"ESTIMATED",[37,43],{"type":38,"name":39,"description":40,"armGroupLabels":41},"BEHAVIORAL","firefighter Sleep Health Coaching Intervention (ffSHC)","This multi-component intervention is based on principles of cognitive behavioral therapy for insomnia. It includes telephone-based sleep health coaching to individuals, targeted training and sleep health education to fire service leaders, agency-level sleep health promotion, and facilitation strategies to internal facilitators.",[42],"Intervention (firefighter Sleep Health Coaching Intervention [ffSHC])",{"type":38,"name":44,"description":45,"armGroupLabels":46},"Control (Minimally Enhanced Usual Care)","The control arm is minimally enhanced usual care. Usual care interventions for sleep disturbance include any health or wellness interventions administered by the agency on the topic of sleep, including occupational health intervention, employee assistance programs, education, signage, and webinars. The type and dose of care will be assessed at each timepoint. Minimal enhancement is a referral to the agency's Employee Assistance Program and will address the ethical problem in the control condition of identifying but not treating a sleep disturbance.",[44],[48,52],{"measure":49,"description":50,"timeFrame":51},"PROMIS Sleep Disturbance questionnaire","PROMIS measures are scored on the T-score metric. 50 is the mean score of a relevant reference population, and 10 is the standard deviation of that population. High scores mean more of the concept being measured.","6 assessments, 6 months apart",{"measure":53,"description":54,"timeFrame":51},"Multidimensional sleep health (MSH) composite","The composite uses weighted summaries of the z-scores of four actigraphic sleep health dimensions: regularity, timing, sleep efficacy, sleep duration and two subjective sleep health dimensions: satisfaction and alertness, derived from items on the PROMIS-SD and PROMIS Sleep Related Impairment (PROMIS-SRI) scale respectively. High scores mean less of the concept being measured (i.e., worse sleep health).",[56,58,61],{"measure":57,"description":50,"timeFrame":51},"PROMIS Sleep Related Impairment questionnaire",{"measure":59,"description":60,"timeFrame":51},"Wake time after sleep onset (WASO), min - actigraphy","This index derived from wrist-worn actigraphy provides an average estimate of the total number of minutes awake after initial sleep onset. High scores mean more of the concept being measured.",{"measure":62,"description":63,"timeFrame":51},"Number of awakenings (NAW) - actigraphy","This index derived from wrist-worn actigraphy provides an average estimate of the total number of awakenings or arousals during the sleep period. High scores mean more of the concept being measured.","ALL","18 Years",null,{"inclusion":68,"exclusion":72,"raw_text":74},[69,70,71],"Required to be employed as career (paid), uniformed fire service workers that must work in a participating fire agency.","Must have moderate or more severe levels of sleep disturbances \\[item-level calibrated T-score of 55 or higher on the 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) questionnaire\\].","Must have private access to a computer or phone for sleep health coaching.",[73],"Children younger than 18 years of age.","Inclusion Criteria:\n\n* Required to be employed as career (paid), uniformed fire service workers that must work in a participating fire agency.\n* Must have moderate or more severe levels of sleep disturbances \\[item-level calibrated T-score of 55 or higher on the 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) questionnaire\\].\n* Must have private access to a computer or phone for sleep health coaching.\n\nExclusion Criteria:\n\n* Children younger than 18 years of age.",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":13,"city":80,"state":81,"zip":82,"country":83,"geoPoint":84},"Tucson","Arizona","85724","United States",{"lat":85,"lon":86},32.22174,-110.92648,[],[],[],[],{"nct_id":4,"conditions":92,"biomarkers":96},[93,94,95],"Disorders of initiating and maintaining sleep","Sleep deprivation","Sleep Disorder",[],{"nct_id":4,"found":15,"summary":66,"prompt_version":66}]