50 Participants NeededMy employer runs this trial

Sleep Enhancement for Insomnia

SY
NA
Overseen ByNoemi Alacron, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: California Polytechnic State University-San Luis Obispo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and user-friendliness of a new app-based sleep program for firefighters with insomnia. Participants will either receive standard sleep education materials or access a special Sleep Health App, along with monthly coaching calls to enhance their sleep. The trial seeks current CalFire Wildfire firefighters or City of San Luis Obispo firefighters who speak English, use an iPhone or iPad, and are interested in improving their sleep. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for better sleep health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this app-based sleep program is safe for firefighters?

Research has shown that digital sleep health programs, like the one in this trial, are generally safe for users. Studies have found that these programs can improve sleep without causing major side effects. For example, a digital insomnia treatment called "Sleep Healthy Using the Internet," designed for doctors, effectively treated insomnia. Although specific side effects weren't detailed, the absence of significant issues suggests these programs are well-tolerated. Additionally, a review of sleep improvement programs found they often enhance sleep quality, with no major safety concerns reported.12345

Why are researchers excited about this trial?

Researchers are excited about the Sleep Well Intervention for insomnia because it offers a unique digital approach tailored specifically for firefighters. Unlike traditional methods like medication and cognitive behavioral therapy, this intervention uses a Sleep Health App coupled with monthly coaching calls to enhance sleep quality. This tech-forward method aims to provide continuous, personalized guidance and support, potentially leading to more sustainable improvements in sleep health for those with demanding, irregular schedules.

What evidence suggests that this trial's treatments could be effective for insomnia?

Research has shown that digital sleep programs like the Sleep Well intervention, which participants in this trial may receive, can improve sleep. For example, one study found that a similar digital therapy led to better sleep quality and fewer insomnia symptoms. Another study demonstrated that behavioral sleep treatments can work as well as medications for short-term sleep problems and can be even more effective over time. Additionally, digital sleep programs have been shown to boost overall well-being, including reducing tiredness and improving mood. These findings suggest that the Sleep Well intervention could be a promising option for better sleep health.14567

Who Is on the Research Team?

SP

Suzanne Phelan, PhD

Principal Investigator

Cal Poly

ST

Selene Tobin, PhD

Principal Investigator

Cal Poly

Are You a Good Fit for This Trial?

This trial is for English-speaking firefighters aged 18 or older in the Central Coast region or San Luis Obispo who use an iPhone/iPad and want to improve their sleep. Volunteers, administrators, and those without Apple devices can't join.

Inclusion Criteria

I am 18 years old or older.
* Have an iPhone /iPad
I want to improve my sleep.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive the Sleep Well intervention or control condition over a three-month period

12 weeks
3 phone calls (monthly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sleep enhancement intervention

Trial Overview

The study is testing a new app-based program designed to help firefighters sleep better compared to usual care chosen by the investigator. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Sleep Well Intervention GroupExperimental Treatment1 Intervention
Group II: Sleep Education Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

California Polytechnic State University-San Luis Obispo

Lead Sponsor

Trials
33
Recruited
3,400+

Citations

Sleep Well! An adapted behavioral sleep intervention ... - PMC

Study Impact: Findings suggest that Sleep Well! is highly feasible to implement in primary care and acceptable to families, with evidence of cultural humility ...

The “SleepWell” intervention for patients with insomnia and ...

Secondary outcomes include reductions in pain intensity and interference, depression and fatigue; improved pain acceptance and quality of life; ...

Sleep Well: Digital Insomnia Treatment Program For ...

The goal of this project is to implement an evidence-based digital therapy to treat insomnia (Sleep Healthy Using the Internet (SHUTi) for physicians to improve ...

4.

bedslab.uoregon.edu

bedslab.uoregon.edu/sleep-well/

Sleep Well! - The BEDS Lab at UO

Summary: This randomized clinical trial (RCT) is a pilot study of Sleep Well!, a brief, behavioral sleep intervention for toddlers and preschoolers who have a ...

A systematic review and meta-analysis of cognitive and ...

This meta-analysis aimed to quantify the efficacy of behavioral and cognitive sleep interventions in adults with poor sleep health, who do not have a sleep ...

Study Details | NCT05748574 | Sleep Well Observation Study

This single-arm, open-label, prospective, observational exploratory pilot study aims at collecting first data on efficacy and safety of "Sleep Well".

Sleep Health Promotion Interventions and Their Effectiveness

Multicomponent Interventions demonstrated improvement but not significantly while 2 studies did not report the sleep duration outcome data.