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CompletedNCT05541692Updated Sep 15, 2022

Efficacy of a Sleep Hygiene Toolkit for Patients in ARU

An interventional study of Sleep Hygiene Toolkit in Sleep Disturbance, Sleep Disorder and Insomnia, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-15.

Sponsored by University of Southern California · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Apr 2022, registered Sep 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Sleep Hygiene Study Abstract:

INTRODUCTION Sleep is integral to the health of a person and can have multifaceted contributions to a person including their physical, cognitive, and psychosocial well-being. However, within a recent survey evaluating the sleep perception of patients within an acute rehabilitation unit (ARU), there was a high prevalence of reported sleep disturbances and poor sleep hygiene compared to at home (Davis et al., 2021). In addition, patients within an ARU generally have an extended length of stay-which could mean many nights of poor sleep hygiene. Given the importance of sleep in facilitating a person's health and recovery versus the challenges the hospital environment poses on patient's sleep hygiene, this study aims to examine the efficacy of a sleep hygiene toolkit provided to the patients admitted to ARU. The sleep hygiene toolkit includes multiple non-pharmaceutical resources addressing sensory stimulation and psychological and emotional needs.

OBJECTIVE This study aims to evaluate the perception of sleep quality experienced by ARU patients utilizing the sleep hygiene toolkit. This study hypothesizes that with the use of a sleep hygiene toolkit, patients will report a positive impact on their sleep quality during their hospital stay.

METHODOLOGY This is a within-subjects study design. All eligible participants will be given the sleep hygiene intervention administered for a period of five days. The sleep hygiene toolkit includes multiple resources including assistive devices (ie. eye masks and ear plugs), sensory-based tools (ie. aromatherapy, music, meditation, and breathing techniques), cognitive behavioral therapy (CBT) activities (ie. addressing anxiety and worry), and education and training on sleep hygiene. The visual analog scales on the Richards-Campbell Sleep Questionnaire will be used to assess patient's overall sleep perception pre- and post-intervention.

CONCLUSION Given this prevalent area of need for patients admitted to ARU, occupational therapists (OT) can offer an additional way to address it. According to the Occupational Therapy Practice Framework (2020), OTs are well-equipped to provide comprehensive treatment to promote a person's sleep preparation and sleep participation. The results will determine the efficacy of a sleep hygiene toolkit for ARU patients in addressing their sleep needs-an important component in a patient's health and recovery during their hospital stay.

SIGNIFICANCE OF TOPIC This study aims to highlight the barriers to successful participation in the occupation of sleep and rest for patients admitted to an acute rehabilitation unit (ARU). The creation of this sleep hygiene toolkit is to address a person's sleep preparation and sleep participation. Although sleep quality and its impact are a topic well studied, there is limited study on occupational therapy led interventions aimed to benefit the patient's sleep quality in an ARU setting.

02

Conditions studied

  • Sleep Disturbance
  • Sleep Disorder
  • Insomnia
  • Critical Illness Myopathy

Keywords

  • Occupational Therapy
  • Sleep
  • ARU
  • ADL
  • Rehab
  • sensory
  • cognitive behavior therapy
  • assistive devices
  • environmental disturbances
03

In context

Sleep Wake Disorders

788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.

This study's enrollment of 30 is below the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.

Browse Sleep Wake Disorders studies →

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients who have the ability and willingness to give informed consent
  • ability to communicate verbally and understand the questionnaires
  • ability to use all components of the intervention
  • are expected to stay in ARU for more than five days.

Exclusion criteria

Exclusion Criteria:

  • Patients with severe cognitive, communication, or behavioral deficits
  • received a score of 7 or less out of 15 on the Brief Interview for Mental Status (BIMS) upon admission
  • unable to use all components of the intervention
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    Efficacy of a sleep hygiene toolkit in ARU

    Pre/post of intervention group (no control)

    Behavioral: Sleep Hygiene Toolkit

Interventions

  • BehavioralSleep Hygiene Toolkit

    The sleep hygiene toolkit includes multiple resources including assistive devices (ie. eye masks and ear plugs), sensory-based tools (ie. aromatherapy, music, meditation, and breathing techniques), cognitive behavioral therapy (CBT) activities (ie. addressing anxiety and worry), and education and training on sleep hygiene.

06

What researchers measure

Primary outcomes

  1. Richards-Campbell Sleep Questionnaire

    Visual analog scale aimed to assess patient's overall sleep perception. Scale parameters are from 0-100 with the higher number correlating to better sleep perception. This questionnaire was used pre- and post-intervention.

    Time frame: 5 days

07

Study locations

1 site
  • Keck Medical Center of USC
    Los Angeles, California 90033, United States
08

References and documents

Individual participant data

Plan to share: Undecided — Publication of data analysis related to intervention study findings

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05541692
Lead sponsor
University of Southern California
Responsible party
Joshua Kotler (Associate Professor, University of Southern California) — Principal investigator
First posted
Sep 15, 2022
Start date
Apr 1, 2022
Primary completion
Jul 4, 2022
Completion
Jul 4, 2022
Last update
Sep 15, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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