Assessing Construction Execution Under Sleep Impairment (ACES)

February 17, 2026 updated by: Nicole Bowles, Oregon Health and Science University

Feasibility of VR Construction Simulations for Detecting Sleep-Related Impairments

The goal of this study is to learn whether virtual reality (VR) construction tasks can detect performance changes associated with prior sleep, and to determine the extent to which these changes can be distinguished from interacting repetitively with VR itself.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After passing a physical assessment and psychological screen, up to 12 participants will be enrolled. Ahead of each 8-hour in-laboratory assessment, participants will be asked to participate in a 1-week at-home monitoring period while continuing with their regular sleep/wake schedule. During this at-home assessment participants will be asked to wear an ActiGraph to objectively assess sleep and complete daily sleep diaries and call into a time-stamped voice-mailbox when going to bed and getting out of bed to confirm sleep/wake times. Participants will be asked to refrain from any alcohol, substances, or intense physical activity during each 1-week at home monitoring period. Similarly, participants are asked to refrain from caffeine consumption 5h prior to the in lab. Participants will then participate in two 8-hour sessions in an in-laboratory setting with a 1-week washout period in-between each in-laboratory visit. The two 8-hour visits will be identical in schedule and instrumentation, differing only in whether VR tasks are administered. Order of visits will be randomized. At each visit, participants will arrive to the laboratory ~6h after their habitual waketime (determined from daily call-ins) and be hooked up for ECG and beat-by-beat blood pressure. They will wear an ActiGraph the entire in-laboratory visit. Participants will also be asked to complete the Karolinska Sleepiness Scale (KSS) questionnaire and the modified Positive Affect-Negative Affect Schedule (PANAS) and the Profile of Mood States (POMS) questionnaire. Finally, participants will be asked to complete construction virtual reality tasks using a virtual reality headset during each of the 4 time points at each visit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Nicole P Bowles, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Fluent in English
  • Tolerate virtual reality system

Exclusion Criteria:

  • Recent shiftwork
  • Recent travel across time zones (>2 in last month)
  • Underlying health conditions (high blood pressure, diabetes, cancer, heart attack, heart failure, angioplasty, heart surgery, etc.)
  • Use of nicotine products such as tobacco or e-cigarettes
  • Use of illicit drugs in the past year
  • Pregnancy
  • Sleep disorders (obstructive sleep apnea)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Construction Virtual Reality Stress Challenges
Participants will be randomly assigned to a laboratory visit that will contain construction virtual reality stress challenges.
Other: Construction Virtual Reality Stress Challenges
Participants will be randomly assigned to a laboratory visit that will contain construction virtual reality stress challenges.
Experimental: No Construction Virtual Reality Stress Challenges
Participants will be randomly assigned to a laboratory visit that will not contain construction virtual reality stress challenges.
Other: No Construction Virtual Reality Stress Challenges
Participants will be randomly assigned to a laboratory visit that will not contain construction virtual reality stress challenges.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility: Recruitment
Time Frame: From first date of recruitment activities to last day of study activities, up to 100 weeks.
Number of eligible participants who enroll in the study.
From first date of recruitment activities to last day of study activities, up to 100 weeks.
Feasibility: Retention
Time Frame: From start of recruitment activities to the end of study activities, up to 100 weeks.
Proportion of eligible participants who enroll and complete all scheduled study visits.
From start of recruitment activities to the end of study activities, up to 100 weeks.
Feasibility: Tolerability of Repeated VR use and Physiologic Monitoring
Time Frame: Assessed each 8-hour in laboratory visit
Proportion of participants able to complete repeated VR tasks and physiologic monitoring without early discontinuation due to discomfort, cybersickness, or adverse symptoms.
Assessed each 8-hour in laboratory visit
Feasibility: Data Completeness and Quality
Time Frame: Through study completion, an average of 1 year
Proportion of planned VR task sessions and physiologic recordings successfully completed with usable data.
Through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Instruction Re-Engagement During VR Tasks
Time Frame: Assessed during each 8-hour in-laboratory visit.
Number of times participants revisit or request task instructions during construction-related VR tasks.
Assessed during each 8-hour in-laboratory visit.
Task Resumption Time Following Disruption
Time Frame: Assessed during each 8-hour in-laboratory visit.
Time (seconds) required for participants to resume task engagement following an interruption or distraction during VR tasks.
Assessed during each 8-hour in-laboratory visit.
VR Task Completion Time
Time Frame: Assessed during each 8-hour in-laboratory visit.
Time required to complete construction-related VR tasks.
Assessed during each 8-hour in-laboratory visit.
Movement Efficiency During VR Tasks
Time Frame: Assessed during each 8-hour in-laboratory visit.
Movement efficiency metrics during VR tasks, including the number of movements required to manipulate objects or complete task objectives.
Assessed during each 8-hour in-laboratory visit.
Controller Interaction Metrics
Time Frame: Assessed during each 8-hour in-laboratory visit.
Controller interaction characteristics during VR tasks, including grip engagement and input patterns.
Assessed during each 8-hour in-laboratory visit.
Gaze Behavior During VR Tasks
Time Frame: Assessed during each 8-hour in-laboratory visit.
Gaze behavior during VR tasks assessed via eye tracking, including fixation duration and spatial distribution of gaze points.
Assessed during each 8-hour in-laboratory visit.
Subjective Sleepiness
Time Frame: 4 Time Points during each 8-hour in-laboratory visit
The Karolinska Sleepiness Scale (KSS) with responses 1 (Extremely alert) to 10 (Extremely sleepy, can't keep awake) will assess subjective sleepiness
4 Time Points during each 8-hour in-laboratory visit
Positive Affect
Time Frame: Assessed at four time points during each 8-hour in-laboratory visit.
Positive affect assessed using the Positive Affect subscale of the Positive and Negative Affect Schedule (PANAS). The Positive Affect subscale consists of 10 items rated on a 5-point Likert scale (1 = very slightly or not at all to 5 = extremely), with total scores ranging from 10 to 50. Higher scores indicate greater positive affect.
Assessed at four time points during each 8-hour in-laboratory visit.
Negative Affect
Time Frame: Assessed at four time points during each 8-hour in-laboratory visit.
Negative affect assessed using the Negative Affect subscale of the Positive and Negative Affect Schedule (PANAS). The Negative Affect subscale consists of 10 items rated on a 5-point Likert scale (1 = very slightly or not at all to 5 = extremely), with total scores ranging from 10 to 50. Higher scores indicate greater negative affect.
Assessed at four time points during each 8-hour in-laboratory visit.
Mood Disturbance
Time Frame: Assessed at four time points during each 8-hour in-laboratory visit.
Mood disturbance assessed using the Profile of Mood States (POMS). The POMS evaluates multiple mood domains (e.g., tension-anxiety, depression-dejection, anger-hostility, vigor, fatigue, confusion). A Total Mood Disturbance (TMD) score is calculated by summing negative mood subscales and subtracting the vigor score. TMD scores typically range from approximately -20 to 100, depending on the version used. Higher scores indicate greater overall mood disturbance, while lower or negative scores indicate more favorable mood states.
Assessed at four time points during each 8-hour in-laboratory visit.
Parasympathetic activity
Time Frame: Assessed during each 8-hour in-laboratory visit.
Assessed using the high frequency power (HF) of the HRV power spectrum (collected from cleaned ECG using Kubios) to estimate cardiac parasympathetic activity as modulated by respiratory sinus arrhythmia during the time of seated rest noted above (but first 5 minutes consistent with field standards).
Assessed during each 8-hour in-laboratory visit.
Systolic Blood Pressure
Time Frame: Assessed during each 8-hour in-laboratory visit.
Will be measured beat-to-beat using a non-invasive device employing the volume-clamp method with hydrostatic correction with measures on alternating fingers every 15 min (NIBP).
Assessed during each 8-hour in-laboratory visit.
Diastolic Blood Pressure
Time Frame: Assessed during each 8-hour in-laboratory visit.
Will be measured beat-to-beat using a non-invasive device employing the volume-clamp method with hydrostatic correction with measures on alternating fingers every 15 min (NIBP).
Assessed during each 8-hour in-laboratory visit.
Electrodermal activity
Time Frame: Assessed during each 8-hour in-laboratory visit.
Continuously assessed using galvanic skin response (GSR) electrodes attached to a fully isolated low voltage amplifier (AD Instruments Ltd). GSR electrodes will be attached to the distal phalange of the index and middle fingers of the non-dominant hand via supplied Velcro tape.
Assessed during each 8-hour in-laboratory visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00029690

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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