Using Cognitive-Behavioral Change and Mobile Technology to Improve RN Sleep and Fatigue

NCT06105307 | Enrolling By Invitation

• 1 other identifier: K01OH012549
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The U.S. registered nurse (RN) workforce is the largest in the Healthcare and Social Assistance Sector and is at high risk for injuries and errors due to poor sleep and fatigue. Shift work (i.e., nights, evenings, rotating shifts) can contribute to RNs not obtaining adequate, restful sleep. Work intensity, including heavy physical and emotional workloads of caring for critically ill patients, can contribute to job stress, resulting in spill-over effects at home when RNs experience difficulties falling and staying asleep. To address work and home sleep barriers, this project proposes the development and pilot testing of RN-SLEEP, a skill-building mobile application designed to improve sleep. RN-SLEEP will provide a convenient, flexible space to learn sleep-enhancing evidence-based shift work-specific strategies, and cognitive-behavioral methods, (e.g., goal setting, relaxation training). Using NIOSH's Research 2 Practice (R2P) approach, the study team will collaborate with participants (N=18-24) from an RN union to refine RN-SLEEP content, integrating current sleep literature (including National Institute for Occupational Safety and Health \[NIOSH\] material) with cognitive-behavioral based training. RN-SLEEP will be pilot-tested using a two-group pretest-posttest study design, comparing sleep outcome measures (duration, quality) of RN-SLEEP participant users (n=38) with participants from an education control group (n=38). Data trends on fatigue, what drives behavior change (beliefs and self-efficacy), and other sleep outcome measures (timing, regularity, efficiency, daytime sleepiness) will be explored. RN-SLEEP goals align with Healthy People 2030, NIOSH's strategic goal to promote safe and healthy work design and well-being through two NIOSH Healthcare and Social Assistance Sector/Healthy Work Design Cross-Sector (HCSA/HWD) intermediate goals. HWD goal 7.2A is to conduct intervention research addressing fatigue (poor sleep sequela) due to suboptimal work designs (shift work) in the healthcare industry. HCSA/HWD goal 7.12A prioritizes interventions designed to impact work and non-work contributors to safety and health. This RN-SLEEP intervention aims to improve sleep by building skills that help RNs overcome obstacles to sleep from work and home, thus improving health and safety. Immediate outputs include a mobile app, designed and tested in collaboration with RNs, to improve sleep. Study results will be disseminated through our union collaborators, nursing conferences and journal publications, and our University's NIOSH-sponsored Education and Research Center social media outlets. Intermediate outcomes include enhancing RN sleep through training rarely available in nursing schools and traditional hospital health and safety training programs. Improving sleep can reduce fatigue and may decrease occupational injuries and errors. RN-SLEEP is adaptable, where future versions could be modified to meet the needs of other HCSA workers (i.e., nursing aides) and workers in other industries (e.g., oil and gas) scheduled to work non-standard work hours. End outcomes include integrating RN-SLEEP into a broader hospital organization intervention to mitigate fatigue risks.

Conditions

Occupational Health; Sleep; Fatigue; Nurse

Keywords

shift worker; training; education; health promotion; sleep duration; sleep quality

Outcome Measures

Primary Outcomes (2)

• Sleep Duration

  Sleep duration will be measured using a 7-day data collection of movement via actigraphy. Daily sleep diaries will support the actigraphy data.

  Baseline and post-intervention (4 and 8-weeks)

• Sleep Quality

  Sleep quality will be measured via self-report survey, the PROMIS Sleep Related Disturbance.

  Baseline and post-intervention (4 and 8-weeks)

Secondary Outcomes (10)

• Sleep timing

  Baseline and post-intervention (4 and 8-weeks)

• Sleep regularity

  Baseline and post-intervention (4 and 8-weeks)

• Sleep efficiency

  Baseline and post-intervention (4 and 8-weeks)

• daytime sleepiness

  Baseline and post-intervention (4 and 8-weeks)

• Sleep efficacy

  Baseline and post-intervention (4 and 8-weeks)

Other Outcomes (1)

• Study feasibility

  post-intervention (4 and 8-weeks)

Study Arms (2)

RN-SLEEP

EXPERIMENTAL

Participants assigned to the RN-SLEEP group will access the training program via a mobile app for one month. The training app will include sleep physiology content, shift work strategies to promote sleep, cognitive behavior therapy for insomnia components, and skill-building techniques to support behavior modification.

Behavioral: RN-SLEEP

Healthy Habit

ACTIVE COMPARATOR

Participants assigned to the Healthy Habit education control group will use a mobile app for one month focused on other healthy behaviors such as exercise tracking.

Behavioral: Healthy Habit - Educational Control

Interventions

RN-SLEEP BEHAVIORAL

RN-SLEEP is a training program delivered via mobile application and designed to help improve the sleep of nurses who engage in shift work. RN-SLEEP aims to include training on strategies for sleeping while working shift work, basics of sleep science and physiology, behavior change components (i.e., goal setting), and components of cognitive behavioral therapy for insomnia (i.e., relaxation).

RN-SLEEP

Healthy Habit - Educational Control BEHAVIORAL

Healthy habit app (i.e., exercise tracking) to act as a control arm for the RN-SLEEP intervention

Also known as: Educational control

Healthy Habit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• working night shift for a minimum of 6-months
• have access to a smart phone.

You may not qualify if:

• who are pregnant or the parent of child(ren) less than 1 year of age
• who have a diagnosed sleep disorder.

Sponsors & Collaborators

• University of Cincinnati: lead
• Washington State University: collaborator

Study Sites (1)

University Of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

Related Publications (1)

• Hittle BM, Wong IS, Smith C, Honn KA, Hamill-Skoch S, Theil A, Lambert J, Gillespie GL. Understanding Nurses' Needs Regarding Tailored, Evidence-Based Sleep Education and Training. J Adv Nurs. 2026 Apr;82(4):3402-3413. doi: 10.1111/jan.70088. Epub 2025 Jul 18.

  PMID: 40679305 DERIVED

MeSH Terms

Conditions

Fatigue; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

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

Model Details: Participants will be randomly assigned to one of two groups: RN-SLEEP group (intervention) or Health Habit group (education control).

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 27, 2023
• Study Start: February 15, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)