- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07477184
Sleep Well Firefighters: An App-based Program to Improve Sleep, Cognition, and Behavioral Health in Firefighters
March 13, 2026 updated by: Selene Tobin, California Polytechnic State University-San Luis Obispo
Intervention to Improve Sleep, Cognition, and Behavioral Health in Firefighters
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Selene Y Tobin, PhD
- Phone Number: 805-756-5653
- Email: sytobin@calpoly.edu
Study Contact Backup
- Name: Noemi Alacron, MS
- Phone Number: 805-756-5694
- Email: noalarco@calpoly.edu
Study Locations
-
-
California
-
San Luis Obispo, California, United States, 93401
- Recruiting
- California Polytechnic University - San Luis Obispo
-
Contact:
- Selene Tobin, PhD
- Phone Number: 805-756-5653
- Email: sytobin@calpoly.edu
-
Contact:
- Noemi Alarcon, MS
- Phone Number: 805-756-5694
- Email: noalarco@calpoly.edu
-
Principal Investigator:
- Selene Tobin, PhD
-
Principal Investigator:
- Suzanne Phelan, PhD
-
Sub-Investigator:
- Sarah Keadle, PhD
-
Sub-Investigator:
- Kelly Bennion, PhD
-
Sub-Investigator:
- James Antony, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria based on self report:
- 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 /iPad
- Age >= 18
- Self-reported interest in improving sleep functioning.
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Sleep Education Control Group
The Sleep Education Control Arm will be provided basic Sleep Education materials that are Standard of Care and available to all Firefighters.
|
Basic Sleep Education materials that are Standard of Care and available to all Firefighters will be administered.
|
|
Experimental: Sleep Well Intervention Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment capability
Time Frame: From Baseline through Study Completion (12 weeks).
|
Recruitment capability: Number of participants enrolled per month (target of 5 enrolled per month)
|
From Baseline through Study Completion (12 weeks).
|
|
Intervention Fidelity
Time Frame: From Baseline through Study Completion (12 weeks).
|
Fidelity: The extent to which an intervention is delivered as intended (target: >80% fidelity score).
|
From Baseline through Study Completion (12 weeks).
|
|
Intervention Adherence
Time Frame: From Baseline (week 0) through Study Completion (12 weeks).
|
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).
|
|
Acceptability
Time Frame: At Study Completion (12 weeks).
|
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).
|
|
Retention
Time Frame: At Baseline (week 0) through Study Completion (week 12).
|
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).
|
|
Assessment procedures
Time Frame: At baseline (week 0) through Study Completion (week 12).
|
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).
|
|
Adherence
Time Frame: At baseline (week 0) through Study completion (week 12).
|
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).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep, movement, and light exposure
Time Frame: 7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12).
|
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).
|
|
BMI
Time Frame: At Baseline (week 0) and at Study Completion (week 12).
|
Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²).
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).
|
|
Depressive symptoms
Time Frame: At Baseline (week 0) and at Study Completion (week 12).
|
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.
|
At Baseline (week 0) and at Study Completion (week 12).
|
|
Caffeine
Time Frame: At Baseline (week 0) and at Study Completion (week 12).
|
A beverage questionnaire will be administered.
Daily caffeine intake will be calculated as average milligrams of caffeine consumed per day.
|
At Baseline (week 0) and at Study Completion (week 12).
|
|
Anxiety
Time Frame: At Baseline (week 0) and at Study Completion (week 12).
|
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.
|
At Baseline (week 0) and at Study Completion (week 12).
|
|
Stress
Time Frame: At Baseline (week 0) and at Study Completion (week 12).
|
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.
|
At Baseline (week 0) and at Study Completion (week 12).
|
|
Quality of Life
Time Frame: At Baseline (week 0) and at Study Completion (week 12).
|
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.
|
At Baseline (week 0) and at Study Completion (week 12).
|
|
Psychomotor Vigilance
Time Frame: At Baseline (week 0) and at Study Completion (week 12).
|
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.
|
At Baseline (week 0) and at Study Completion (week 12).
|
|
Sleep Diary
Time Frame: 7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12).
|
Participants will be asked to complete a log reporting the time they got into bed and got out of bed.
|
7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12).
|
|
Epworth Sleepiness Scale (ESS) Score
Time Frame: Baseline (Week 0) to Post-Intervention (Week 12)
|
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)
|
|
Pittsburgh Sleep Quality Index (PSQI) Global Score
Time Frame: Baseline (Week 0) to Post-Intervention (Week 12)
|
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.
|
Baseline (Week 0) to Post-Intervention (Week 12)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Suzanne Phelan, PhD, Cal Poly
- Principal Investigator: Selene Tobin, PhD, Cal Poly
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
January 13, 2026
First Submitted That Met QC Criteria
March 13, 2026
First Posted (Actual)
March 17, 2026
Study Record Updates
Last Update Posted (Actual)
March 17, 2026
Last Update Submitted That Met QC Criteria
March 13, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
De-identified individual participant data will not be made publicly available.
Aggregate results will be reported in peer-reviewed publications and scientific presentations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physical Activity
-
Muğla Sıtkı Koçman UniversityEge UniversityCompletedPhysical Activity | Physical Activity Behavior | Physical Activity LevelsTurkey
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
Universidad Pedagogica Nacional, ColombiaEnrolling by invitationPhysical Activity | Running | Running Performance | Running Endurance | Physical Activity in Adults | Physical Activity IntensityColombia
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
University of ManitobaResearch ManitobaCompletedPhysical Activity | Physical Activity Self-Definition
-
Odense University HospitalUniversity of Southern DenmarkRecruitingQuality of Life | Physical Activity | Physical Disability | Physical Function | ParticipationDenmark
-
Universidade do PortoActive, not recruitingPhysical Activity | Physical Fitness | Well BeingPortugal
-
Firat UniversityNot yet recruitingUniversity Students | Physical Activity Level | Postural Awareness | Physical Activity AttitudeTurkey
-
Pham Ngoc Thach University of MedicineCompletedModerate Physical Activity (MPA) | Vigorous Physical Activity (VPA) | Moderate to Vigorous Physical Activity (MVPA) | Total of Sleep Time (TST)Vietnam
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
Clinical Trials on Standard of Care (Investigator Choice)
-
Western UniversityNot yet recruiting
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...Fondazione Policlinico Universitario Agostino Gemelli IRCCS; San Raffaele University... and other collaboratorsRecruiting
-
iOncturaActive, not recruitingOcular Melanoma | Uveal MelanomaSpain, United Kingdom, Italy
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara; IRCCS Azienda... and other collaboratorsRecruitingAdenoid Cystic Carcinoma of the Salivary Gland | Adenoid Cystic Carcinoma of the Head and NeckItaly
-
Advanced Reconstructive Surgery AllianceNot yet recruiting
-
Ole HyldegaardKarolinska University Hospital; Turku University Hospital; Oslo University Hospital and other collaboratorsRecruitingNecrotizing Soft Tissue InfectionBelgium
-
iOMEDICO AGBerlin Chemie AGNot yet recruiting
-
Mayo ClinicEnrolling by invitationAbdominal Surgery Patients | Drains | Surgical DrainUnited States
-
Maastricht University Medical CenterUniversity Medical Center Groningen; Maastricht UniversityWithdrawnChronic Heart Failure | Acute Decompensated Heart FailureNetherlands
-
Ospedale San DonatoCompletedDiabetic Foot | Postoperative Wound HealingItaly