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

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

Study Contact Backup

Study Locations

    • California
      • San Luis Obispo, California, United States, 93401
        • Recruiting
        • California Polytechnic University - San Luis Obispo
        • Contact:
        • Contact:
        • 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

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.

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