Sleep HealthNCT07477184
Sleep Well Firefighters: An App-based Program to Improve Sleep, Cognition, and Behavioral Health in Firefighters
A study testing Sleep enhancement intervention in people with Sleep Health and Stress, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Health, Stress, Anxiety
- What is being tested?
- Sleep enhancement intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
California Polytechnic University - San Luis Obispo
San Luis Obispo, California, 93401
Selene Tobin, PhD, 805-756-5653, sytobin@calpoly.edu
Noemi Alarcon, MS, 805-756-5694, noalarco@calpoly.edu
About this study
Official title: 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.
Read the 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
- Conditions
- Sleep Health, Stress, Anxiety, Physical Activity, Nutrition, Cognition
- Being tested
- Sleep enhancement intervention, Standard of Care (Investigator Choice)
- Keywords
- Firefighters, Behavioral Sleep Health, Digital Health, Cognition
- Medical subject headings
- Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep enhancement interventionBehavioural
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.
Standard of Care (Investigator Choice)Behavioural
Basic Sleep Education materials that are Standard of Care and available to all Firefighters will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Education Control Group | Active comparator | The Sleep Education Control Arm will be provided basic Sleep Education materials that are Standard of Care and available to all Firefighters. Receives: Behavioral: Standard of Care (Investigator Choice) |
| Sleep Well Intervention Group | Experimental | 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. Receives: Behavioral: Sleep enhancement intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment capability
Recruitment capability: Number of participants enrolled per month (target of 5 enrolled per month)
Measured: From Baseline through Study Completion (12 weeks).
Intervention Fidelity
Fidelity: The extent to which an intervention is delivered as intended (target: >80% fidelity score).
Measured: From Baseline through Study Completion (12 weeks).
Intervention Adherence
Change in sleep behaviors assessed via in-app tracking (i.e., self-report of sleep behaviors over the study intervention period).
Measured: From Baseline (week 0) through Study Completion (12 weeks).
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.
Measured: At Study Completion (12 weeks).
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);
Measured: At Baseline (week 0) through Study Completion (week 12).
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.
Measured: At baseline (week 0) through Study Completion (week 12).
Adherence
Logins on the mobile Sleep Well App (Goal: >75% of expected logins on the mobile Sleep Well app)
Measured: At baseline (week 0) through Study completion (week 12).
Secondary outcomes (11)
Sleep, movement, and light exposure
Sleep, circadian rhythm, movement, temperature, and exposure to light will be objectively measuring using the wrist-worn Gene Active
Measured: 7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12).
BMI
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.
Measured: At Baseline (week 0) and at Study Completion (week 12).
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.
Measured: At Baseline (week 0) and at Study Completion (week 12).
Caffeine
A beverage questionnaire will be administered. Daily caffeine intake will be calculated as average milligrams of caffeine consumed per day.
Measured: At Baseline (week 0) and at Study Completion (week 12).
Anxiety
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.
Measured: At Baseline (week 0) and at Study Completion (week 12).
Stress
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.
Measured: At Baseline (week 0) and at Study Completion (week 12).
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.
Measured: At Baseline (week 0) and at Study Completion (week 12).
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.
Measured: At Baseline (week 0) and at Study Completion (week 12).
Sleep Diary
Participants will be asked to complete a log reporting the time they got into bed and got out of bed.
Measured: 7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12).
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.
Measured: Baseline (Week 0) to Post-Intervention (Week 12)
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.
Measured: Baseline (Week 0) to Post-Intervention (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start5 Jan 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California Polytechnic State University-San Luis Obispo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selene Tobin, California Polytechnic State University-San Luis Obispo
- Investigators
- Suzanne Phelan, PhD, Principal investigator, Cal PolySelene Tobin, PhD, Principal investigator, Cal Poly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477184
- Sponsor's protocol ID
- 2023-179
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will not be made publicly available. Aggregate results will be reported in peer-reviewed publications and scientific presentations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Improve Sleep, Cognition, and Behavioral Health in Firefighters
- ClinicalTrials.gov ID
- NCT07477184
- Acronym / sponsor ID
- 2023-179
- Conditions
- Sleep Health, Stress, Anxiety, Physical Activity, Nutrition, Cognition
- Keywords
- Firefighters, Behavioral Sleep Health, Digital Health, Cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- California Polytechnic State University-San Luis ObispoUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Education Control Group | Active comparator | Behavioral: Standard of Care (Investigator Choice)The Sleep Education Control Arm will be provided basic Sleep Education materials that are Standard of Care and available to all Firefighters. |
| Sleep Well Intervention Group | Experimental | Behavioral: Sleep enhancement interventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep enhancement interventionThe 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. | Behavioural | Sleep Well Intervention Group |
| Standard of Care (Investigator Choice)Basic Sleep Education materials that are Standard of Care and available to all Firefighters will be administered. | Behavioural | Sleep Education Control Group |
Primary outcome
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)
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).
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).
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.
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);
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.
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)
11 secondary outcomes
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).
BMI
Time frame: At Baseline (week 0) and at Study Completion (week 12).
Depressive symptoms
Time frame: At Baseline (week 0) and at Study Completion (week 12).
Caffeine
Time frame: At Baseline (week 0) and at Study Completion (week 12).
Anxiety
Time frame: At Baseline (week 0) and at Study Completion (week 12).
Stress
Time frame: 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).
Psychomotor Vigilance
Time frame: 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).
Epworth Sleepiness Scale (ESS) Score
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be made publicly available. Aggregate results will be reported in peer-reviewed publications and scientific presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suzanne Phelan, PhD principal investigator
Cal Poly
Selene Tobin, PhD principal investigator
Cal Poly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep enhancement intervention in people with Sleep Health and Stress, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selene Y Tobin, PhD (805-756-5653, sytobin@calpoly.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment capability (time frame: From Baseline through Study Completion (12 weeks).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.