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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Standard of Care (Investigator Choice)
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
California Polytechnic State University-San Luis Obispo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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