[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07477184":3,"trial-entities:NCT07477184":169,"trial-summary:NCT07477184":172},{"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":25,"study_type":29,"primary_purpose":14,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":47,"secondary_outcomes":75,"sex":110,"minimum_age":111,"maximum_age":112,"healthy_volunteers":113,"eligibility_criteria":114,"std_ages":124,"locations":127,"central_contacts":158,"overall_officials":163,"references":167,"see_also_links":168},"NCT07477184","2023-179","Sleep Well Firefighters: An App-based Program to Improve Sleep, Cognition, and Behavioral Health in Firefighters","Intervention to Improve Sleep, Cognition, and Behavioral Health in Firefighters","RECRUITING","2026-09","2026-03","2026-03-17","2026-01-05","California Polytechnic State University-San Luis Obispo","OTHER",false,"The purpose of this pilot study is to examine the feasibility and acceptability of an app-based sleep program designed to help firefighters improve their sleep.","The purpose of this pilot study is to examine the feasibility and acceptability of an app-based sleep program designed to help firefighters improve their sleep. This trial will recruit firefighters working on the Central Coast of California. Upon completing screening procedures and an informed consent, participants will be asked to complete questionnaires related to sleep, behavioral health, and cognition and sleep patterns will be objectively assessed using research grade wrist-worn accelerometers. Participants will then be randomized to receive the Sleep Well intervention (mobile iOS app + monthly phone coaching; N=25) or a control condition (handout on sleep in firefighters; N=25). Over a three month study period, participants randomized to the Sleep Well intervention will be asked to 1) track their sleep, physical activity, eating, and stress; 2) complete weekly, in-app learning modules informed by social cognitive theory and cognitive behavioral therapy for insomnia covering topics such as sleep hygiene, bedtime routines, healthy eating and activity patterns, and managing stress; and 3) participate in three monthly coaching phone calls with a trained study interventionist. After the three month study period, all participants will be asked to repeat baseline assessments. Those in the Sleep Well intervention group will also be asked for user feedback. Quantitative data will inform feasibility of digitally delivered, behavioral sleep programming designed for firefighters. Findings will inform intervention strategies targeting healthy sleep behaviors to improve health and cognition in firefighters and guide the study protocol for a full-scale trial",[19,20,21,22,23,24],"Sleep Health","Stress","Anxiety","Physical Activity","Nutrition","Cognition",[26,27,28,24],"Firefighters","Behavioral Sleep Health","Digital Health","INTERVENTIONAL",[31],"NA",{"count":33,"type":34},50,"ESTIMATED",[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40},"BEHAVIORAL","Sleep enhancement intervention","The Sleep Well Intervention Group will receive access to a digital Sleep Health App designed for Firefighters and will be asked to participate in monthly coaching phone calls aimed at improving their sleep health.",[41],"Sleep Well Intervention Group",{"type":37,"name":43,"description":44,"armGroupLabels":45},"Standard of Care (Investigator Choice)","Basic Sleep Education materials that are Standard of Care and available to all Firefighters will be administered.",[46],"Sleep Education Control Group",[48,52,55,59,63,67,71],{"measure":49,"description":50,"timeFrame":51},"Recruitment capability","Recruitment capability: Number of participants enrolled per month (target of 5 enrolled per month)","From Baseline through Study Completion (12 weeks).",{"measure":53,"description":54,"timeFrame":51},"Intervention Fidelity","Fidelity: The extent to which an intervention is delivered as intended (target: \\>80% fidelity score).",{"measure":56,"description":57,"timeFrame":58},"Intervention Adherence","Change in sleep behaviors assessed via in-app tracking (i.e., self-report of sleep behaviors over the study intervention period).","From Baseline (week 0) through Study Completion (12 weeks).",{"measure":60,"description":61,"timeFrame":62},"Acceptability","Participants will be asked to rate the usefulness and satisfaction with app and phone-sessions, using a questionnaire that includes rating scales of various aspects of the program.","At Study Completion (12 weeks).",{"measure":64,"description":65,"timeFrame":66},"Retention","Retention: Number of participants who remained in the study throughout the project period of the total number of participants recruited at baseline (Target of 80% retention rate; Reasons for dropout will be collected);","At Baseline (week 0) through Study Completion (week 12).",{"measure":68,"description":69,"timeFrame":70},"Assessment procedures","Assessment procedures: The extent to which study assessments can be administered as planned; assessment procedures are acceptable to participants; and data collection is complete.","At baseline (week 0) through Study Completion (week 12).",{"measure":72,"description":73,"timeFrame":74},"Adherence","Logins on the mobile Sleep Well App (Goal: \\>75% of expected logins on the mobile Sleep Well app)","At baseline (week 0) through Study completion (week 12).",[76,80,84,87,90,92,94,97,100,103,107],{"measure":77,"description":78,"timeFrame":79},"Sleep, movement, and light exposure","Sleep, circadian rhythm, movement, temperature, and exposure to light will be objectively measuring using the wrist-worn Gene Active","7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12).",{"measure":81,"description":82,"timeFrame":83},"BMI","Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg\u002Fm²). Weight will be measured using a calibrated digital scale and height using a stadiometer. Self-reported values may be used if direct measurement is not available.","At Baseline (week 0) and at Study Completion (week 12).",{"measure":85,"description":86,"timeFrame":83},"Depressive symptoms","Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report measure of depression severity. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 27, with higher scores indicating greater depressive symptom severity.",{"measure":88,"description":89,"timeFrame":83},"Caffeine","A beverage questionnaire will be administered. Daily caffeine intake will be calculated as average milligrams of caffeine consumed per day.",{"measure":21,"description":91,"timeFrame":83},"Anxiety levels will be assessed using the Beck Anxiety Inventory. The Beck Anxiety Inventory (BAI) is a 21-item self-report measure assessing anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating greater anxiety severity.",{"measure":20,"description":93,"timeFrame":83},"Stress will be measured using the Perceived Stress Scale. The Perceived Stress Scale-10 (PSS-10) is a 10-item self-report measure assessing perceived stress over the past month. Total scores range from 0 to 40, with higher scores indicating greater perceived stress.",{"measure":95,"description":96,"timeFrame":83},"Quality of Life","Quality of life will be measured using Short Form Health Survey - SF-12. Scores range from 0 to 100, with higher scores indicating better mental health status.",{"measure":98,"description":99,"timeFrame":83},"Psychomotor Vigilance","Attention will be measured using a psychomotor vigilance task that collects reaction time. The primary metric will be mean reaction time in milliseconds (ms), with higher values indicating slower responses and reduced vigilance.",{"measure":101,"description":102,"timeFrame":79},"Sleep Diary","Participants will be asked to complete a log reporting the time they got into bed and got out of bed.",{"measure":104,"description":105,"timeFrame":106},"Epworth Sleepiness Scale (ESS) Score","The Epworth Sleepiness Scale (ESS) is an 8-item self-report questionnaire assessing daytime sleepiness. Total scores range from 0 to 24, with higher scores indicating greater daytime sleepiness.","Baseline (Week 0) to Post-Intervention (Week 12)",{"measure":108,"description":109,"timeFrame":106},"Pittsburgh Sleep Quality Index (PSQI) Global Score","The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report measure assessing sleep quality. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.","ALL","18 Years",null,true,{"inclusion":115,"exclusion":121,"raw_text":123},[116,117,118,119,120],"Current CalFire Wildfire firefighter in Central Coast region or City of San Luis Obispo Firefighter (non-volunteer and not a primarily administrator status)","English Speaking","Have an iPhone \u002FiPad","Age \\>= 18","Self-reported interest in improving sleep functioning.",[122],"none","Inclusion Criteria based on self report:\n\n* Current CalFire Wildfire firefighter in Central Coast region or City of San Luis Obispo Firefighter (non-volunteer and not a primarily administrator status)\n* English Speaking\n* Have an iPhone \u002FiPad\n* Age \\>= 18\n* Self-reported interest in improving sleep functioning.\n\nExclusion Criteria:\n\n* none",[125,126],"ADULT","OLDER_ADULT",[128],{"facility":129,"status":8,"city":130,"state":131,"zip":132,"country":133,"contacts":134,"geoPoint":155},"California Polytechnic University - San Luis Obispo","San Luis Obispo","California","93401","United States",[135,140,144,146,148,151,153],{"name":136,"role":137,"phone":138,"email":139},"Selene Tobin, PhD","CONTACT","805-756-5653","sytobin@calpoly.edu",{"name":141,"role":137,"phone":142,"email":143},"Noemi Alarcon, MS","805-756-5694","noalarco@calpoly.edu",{"name":136,"role":145},"PRINCIPAL_INVESTIGATOR",{"name":147,"role":145},"Suzanne Phelan, PhD",{"name":149,"role":150},"Sarah Keadle, PhD","SUB_INVESTIGATOR",{"name":152,"role":150},"Kelly Bennion, PhD",{"name":154,"role":150},"James Antony, PhD",{"lat":156,"lon":157},35.28275,-120.65962,[159,161],{"name":160,"role":137,"phone":138,"email":139},"Selene Y Tobin, PhD",{"name":162,"role":137,"phone":142,"email":143},"Noemi Alacron, MS",[164,166],{"name":147,"affiliation":165,"role":145},"Cal Poly",{"name":136,"affiliation":165,"role":145},[],[],{"nct_id":4,"conditions":170,"biomarkers":171},[21,24,19,20],[],{"nct_id":4,"found":113,"summary":173,"prompt_version":182},{"design":174,"status":175,"heading":6,"summary":176,"follow_up":177,"word_count":178,"commitments":179,"compensation":180,"drugs_mentioned":181},"This is an interventional study with a planned enrollment of 50 participants. It compares an app-based sleep program to standard sleep education materials.","completed","This study is testing an app-based program called \"Sleep Well Intervention Group\" to see if it can help firefighters improve their sleep, thinking skills (cognition), and overall mental well-being. You might be able to join if you are a CalFire Wildfire firefighter in the Central Coast region or a City of San Luis Obispo Firefighter, speak English, have an iPhone\u002FiPad, are at least 18 years old, and are interested in improving your sleep. The study aims to find out if this program is practical and acceptable for firefighters. The current status of this study is unclear.","Participants will be followed from baseline through study completion, which is 12 weeks.",96,"You would complete questionnaires, wear a wrist device to track sleep, and either use a mobile app with monthly coaching calls for three months or receive basic sleep education materials. After three months, you would repeat the initial assessments.","Not stated in the trial record.",[],"v2"]