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Recruiting NCT07477184

Sleep Well Firefighters: An App-based Program to Improve Sleep, Cognition, and Behavioral Health in Firefighters

No phase Interventional Sleep Health Stress Anxiety Physical Activity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sleep enhancement intervention, Standard of Care (Investigator Choice).
Who it may be relevant to
Registry conditions: Sleep Health, Stress, Anxiety, Physical Activity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Intervention to Improve Sleep, Cognition, and Behavioral Health in Firefighters

Overview

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

Interventions

  • 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.
  • Behavioral Standard of Care (Investigator Choice)
    Basic Sleep Education materials that are Standard of Care and available to all Firefighters will be administered.

Primary outcome measures

  • Recruitment capability [Time frame: From Baseline through Study Completion (12 weeks).]
  • Intervention Fidelity [Time frame: From Baseline through Study Completion (12 weeks).]
  • Intervention Adherence [Time frame: From Baseline (week 0) through Study Completion (12 weeks).]
  • Acceptability [Time frame: At Study Completion (12 weeks).]
  • Retention [Time frame: At Baseline (week 0) through Study Completion (week 12).]
  • Assessment procedures [Time frame: At baseline (week 0) through Study Completion (week 12).]
  • Adherence [Time frame: At baseline (week 0) through Study completion (week 12).]
Secondary outcome measures (11)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • California Polytechnic University - San Luis Obispo — San Luis Obispo

Identifiers

NCT: NCT07477184 · 2023-179

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗