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Behavioral Intervention

Sleep Health Coaching for Insomnia (SAFFIRE Trial)

Phase 4

Waitlist Available

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Required to be employed as career (paid), uniformed fire service workers that must work in a participating fire agency

Must have moderate or more severe levels of sleep disturbances (item-level calibrated T-score of 55 or higher on the 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) questionnaire)

Must not have

Children younger than 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 assessments, approximately 1 year apart

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to study the effectiveness of a sleep improvement program for firefighters in Arizona. Many firefighters report poor sleep quality or short sleep duration, with a significant portion also having sleep disorders. The study will

Who is the study for?

This trial is for firefighters in Arizona who may be experiencing poor sleep quality or disorders like insomnia, parasomnia, and shift work sleep disorder. Participants should be part of an agency willing to implement the study's interventions.

What is being tested?

The study tests a firefighter-specific Sleep Health Coaching Intervention (ffSHC) informed by Cognitive Behavioral Therapy for Insomnia against minimally enhanced usual care to see if it improves sleep among firefighters.

What are the potential side effects?

Since this intervention involves coaching rather than medication, side effects are minimal but could include potential discomfort from discussing personal sleep habits or changing established routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a paid firefighter working at a participating fire agency.

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I have moderate to severe sleep problems.

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I have a computer or phone to use for sleep health coaching.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 assessments, approximately 1 year apart

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 assessments, approximately 1 year apart

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 assessments, approximately 1 year apart for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Multidimensional sleep health (MSH) composite

PROMIS Sleep Disturbance questionnaire

Secondary study objectives

Number of awakenings (NAW) - actigraphy

PROMIS Sleep Related Impairment questionnaire

Wake time after sleep onset (WASO), min - actigraphy

Other study objectives

Blood pressure

Heart rate

Occupational health clinic assessments-1, CVD

+2 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention (firefighter Sleep Health Coaching Intervention [ffSHC])Experimental Treatment1 Intervention

In this arm, fire service employees receive a structured sleep health intervention based on Cognitive Behavioral Therapy for Insomnia (CBTi). The intervention includes sleep health promotion, telephone-administered sleep coaching, and implementation strategies to promote better sleep practices. Each cluster will transition from the control arm to this intervention at a fixed time, and outcome data will be collected at multiple time points during and after the intervention phase to assess its effectiveness.

Group II: Control (Minimally Enhanced Usual Care)Active Control1 Intervention

In this arm, fire service workers receive usual care with minimal enhancements but without the full sleep health intervention. During this phase, clusters will serve as the control group, and data on sleep health and related outcomes will be collected for comparison against the intervention phase. Each cluster will remain in this arm until a predetermined time point, at which they transition to the intervention arm after a one-month preparation phase.

0 / 4Eligibility criteria met