NCT07477184

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Jan 2026Sep 2026

Study Start

First participant enrolled

January 5, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

January 13, 2026

Last Update Submit

March 13, 2026

Conditions

Keywords

FirefightersBehavioral Sleep HealthDigital HealthCognition

Outcome Measures

Primary Outcomes (7)

  • Recruitment capability

    Recruitment capability: Number of participants enrolled per month (target of 5 enrolled per month)

    From Baseline through Study Completion (12 weeks).

  • Intervention Fidelity

    Fidelity: The extent to which an intervention is delivered as intended (target: \>80% fidelity score).

    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).

    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.

    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);

    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.

    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)

    At baseline (week 0) through Study completion (week 12).

Secondary Outcomes (11)

  • Sleep, movement, and light exposure

    7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12).

  • BMI

    At Baseline (week 0) and at Study Completion (week 12).

  • Depressive symptoms

    At Baseline (week 0) and at Study Completion (week 12).

  • Caffeine

    At Baseline (week 0) and at Study Completion (week 12).

  • Anxiety

    At Baseline (week 0) and at Study Completion (week 12).

  • +6 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Sleep enhancement intervention

Interventions

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.

Sleep Well Intervention Group

Basic Sleep Education materials that are Standard of Care and available to all Firefighters will be administered.

Sleep Education Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Polytechnic University - San Luis Obispo

San Luis Obispo, California, 93401, United States

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersMotor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Suzanne Phelan, PhD

    Cal Poly

    PRINCIPAL INVESTIGATOR
  • Selene Tobin, PhD

    Cal Poly

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Selene Y Tobin, PhD

CONTACT

Noemi Alacron, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 13, 2026

First Posted

March 17, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data will not be made publicly available. Aggregate results will be reported in peer-reviewed publications and scientific presentations.

Locations