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Spinal Cord Injury CervicalPhase 2NCT07062796

Access-H20: Sensor-driven Smart Faucet

A Phase 2 study testing Water Faucet in people with Spinal Cord Injury Cervical, run by Old Dominion University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of the SBIR Phase II study is to evaluate the updated Access-H2O™ system, a sensor-driven smart faucet developed during the Phase I SBIR project, to enhance independent drinking and grooming among individuals with spinal cord injury (SCI) in both clinical and home settings. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injury Cervical
What is being tested?
Water Faucet
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
3 Jun 2025to 13 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Individuals with ages 18 to 90 years old are eligible for the study. Individuals should have been screened by a physical or occupational therapist to verify your spinal cord injury (SCI), they are able to follow instructions, they are able to move their eyes and head up, down, and right to activate sensors, and they are able to safely access a bathroom at home.
  • age 18 years or older with a confirmed diagnosis of SCI; (2) residence in a home environment that can support installation of the Access H2O™ smart faucet; (3) ability to provide informed consent or have a legal guardian provide consent on their behalf; (4) stable health status, as determined by clinical evaluation; (5) ability to move the head up, down, left, and right to activate sensors; (6) ability to safely access the sink area where the Access H2O™ faucet is installed; and (7) literacy and ability to follow instructions within the Access H2O™ mobile app.

Who cannot join

  • Individuals have cognitive deficits, mental health, or medical conditions that would keep them from participating in this study.
  • Year 2 study:
  • severe cognitive impairment that prevents the participant from using the device as intended; (2) any medical condition that contraindicates the use of the Access H2O™ smart faucet; and (3) participation in another clinical trial that could interfere with the outcomes of this study.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Monarch Physical Therapy Clinic

    Norfolk, Virginia, 23508

Other trials in United States

About this study

Official title: Access-H20: Sensor-driven Smart Faucet to Enable and Empower Independent Drinking and Grooming for Individuals Impacted by Spinal Cord Injury

The objective of the SBIR Phase II study is to evaluate the updated Access-H2O™ system, a sensor-driven smart faucet developed during the Phase I SBIR project, to enhance independent drinking and grooming among individuals with spinal cord injury (SCI) in both clinical and home settings. SCI significantly impairs functional independence and the ability to perform activities of daily living (ADLs), with greater loss of function associated with higher and more complete injuries. In particular, individuals with injuries above the C5-C7 level often experience substantial upper extremity impairment, limiting their ability to use their arms and hands for essential tasks such as eating, drinking, and grooming. Access to water is therefore critical for supporting independence and facilitating the successful completion of ADLs in this population.

The commercialization of a smart faucet system capable of automatically delivering water at target temperature, flow rate, and nozzle settings tailored to specific ADLs has the potential to substantially improve independence and quality of life for individuals with SCI. The Access-H2O™ faucet was developed and tested during the SBIR Phase I project in 2024 and was subsequently upgraded and refined based on Phase I findings. Participants with SCI, along with control participants, were recruited to evaluate the feasibility and usability of the enhanced faucet system in both clinical and in-home settings. The updated system incorporates voice, motion, and remote-control interfaces to regulate water flow and temperature for ADLs, including drinking, grooming, and washing.

Read the detailed description

Conventionally, a bathroom faucet includes a hot and cold-water knob used to control flow of water through the faucet, which is utilized for hand washing, face washing, rinsing after brushing, etc. However, existing faucets are inconvenient to use for purposes other than conventional hand washing, unhygienic, and result in wasting large amounts of water. Existing faucets make it difficult for individuals with cervical spinal cord injury (SCI) to carry out basic activities of daily living (ADLs), such as drinking, rinsing their mouths, and washing their faces.

To address these challenges, Nasoni Inc. develop the new faucet, Access H2OTM faucet, to address these challenges. During the Phase I study from 2022-2023, we achieved the following objectives: 1) Successfully designing and producing a prototype of the Access H2O faucet that met input specifications in bench testing, and 2) Developing control algorithms using sensor-based inputs successfully allowed both control and SCI subjects to accurately access desired water. The clinical feasibility study showed that the faucet could improve water access for SCI subjects and improve their ADLs. SCI subjects showed a strong preference for Access-H2O faucets compared to traditional methods.

Before proceeding with commercialization, it is necessary to optimize the operational functions of the prototype. In the Phase II study, the engineering team has planned to enhance the prototype's faucet form factor design and sensors based on the findings from the Phase I study. These enhancements include: 1) optimizing the form factor and nozzle water delivery, 2) refining the sensor \& display components, and 3) expanding sensor integration capabilities. Also, the team has improved the water control mechanisms established in Phase I by integrating Access-H2O faucet intelligent algorithms and developing a supporting digital platform with a mobile app to support product efficacy, usability, and field maintenance.

Specifically, Phase II evaluates improvements in faucet form factor, sensor placement, manufacturing-ready hardware, and interaction modalities, all informed by Phase I user feedback and clinical observations. Accordingly, the objective of this Phase II study is to assess system refinements that impact real-world independence and usability beyond initial feasibility. The Phase II study comprises two sets of studies conducted in Year 1 and Year 2 separately. They were labelled as the Year 1 testing study and the Year 2 testing study.

The Year 1 testing was conducted in a clinical setting. The specific aims of the feasibility assessment were to evaluate the feasibility and usability of the refined Access-H2O™ faucet system-controlled via voice commands, hand motion, and a wireless remote-to drink water (drinking), rinse the face (grooming), or wash hair (washing; optional).

The Year 2 testing was conducted in each participant's home. The specific aims of the feasibility assessment were to evaluate whether participants could use the refined Access-H2O™ faucet system-controlled via voice commands, hand motion, and a wireless remote-to drink water (drinking), rinse their face (grooming), or wash their hair (optional) in a home setting.

Besides the unique water floor technology, the Access-H2O™ faucet system equips hand-free methods for water access and water temperature control:

  • Voice control via keyword recognition using Alexa integration
  • Motion control using a time-of-flight (ToF) proximity sensor
  • Wireless remote control with tactile buttons (newly introduced in Phase II)
  • Raised spout (+5 cm) and re-angled water stream for seated face washing and hair rinsing
  • Temperature control system using PID logic and a 40°C thermal safety cap

There are three control sensors: voice, motion, and remote controls. Voice recognition is enabled through integration with a pre-existing Amazon Alexa device using a custom Alexa Skill. Users activate the system by saying "Alexa" followed by predefined commands (e.g., "Faucet on" or "Turn on Grooming Mode") to control faucet operation, mode selection, and temperature hands-free. Motion detection is implemented using ToF proximity sensors mounted at the base of the faucet to detect hand motion to activate the faucet for water dispensing. A handheld wireless remote control that provides an alternative input method for operating the faucet with maximal flexibility in placement and use. The remote communicates with the faucet via Bluetooth and allows users to activate or deactivate water flow and select among predefined water delivery modes. The remote may be positioned on a nearby surface or affixed using hook-and-loop fasteners, allowing users to locate the control within comfortable reach. On the front of the control, three buttons labeled "F," "W," and "G" correspond to fountain, washing, and grooming, respectively.

In the Year 1 testing, a total of 18 subjects living with SCI, called SCI subjects, and 5 control subjects were recruited in an outpatient rehabilitation clinic. Controls without limitations in head, trunk, or arm movement were used to verify that all faucet functions operated correctly and that water was accessible for drinking, rinsing, and grooming. This preliminary assessment by the controls was conducted after installing the Access-H2OTM faucet in the rehabilitation clinic and before SCI subjects' participation.

The feasibility testing was conducted to test the faucet's voice, motion, and remote control sensors for SCI subjects' ADLs - drinking, grooming, or washing (optional). We sought answers to the following questions: 1) Can the test participants use voice, motion, and remote controls to activate the faucet to get their mouth to drink/hydrate? 2) Can the test participants use the three controls to rinse a quarter-sized area of soap partially or fully from their left or right cheek or 3) can the test participants use the three controls to wash a quarter soap in hairs.

In the Year 1 testing, all SCI subjects who relied on wheelchairs were seated in their own manual or power wheelchairs. The wheelchairs were positioned in front of a sink equipped with the Access-H2OTM faucet. Sufficient space was provided to accommodate the subjects' legs under the sink, ensuring standardized data collection. Then, the physical therapist who provided scripted instructions to each participant on how to turn on the faucet, and then turn off the faucet. During setup, the system was tested and calibrated to ensure proper operation. If any function did not meet the standard, manual adjustments were made as needed. For example, during setup, flow and spray angles for fountain mode and grooming mode can be customized by adjusting valve angles or water pressure to achieve the preferred water flow trajectory.

Once the system was ready, each SCI subject was asked to place his or her hand by the motion sensor (motion control), use a speech speaker (voice control), and push the remote control to activate water output modes for drinking, grooming, or washing. For example, to test eye gaze control, a subject looked at the right side of the eye gaze sensor to activate fountain mode for drinking and looked at the left side of the sensor to activate grooming mode for spray pattern flow to wash a quarter-sized area of soap from the left or right cheek. Each participant performed the same activity (drinking, grooming, or washing) and sensor controls (voice, motion, and remote) three times. For example, a subject used the voice control to activate fountain mode for drinking and repeated the procedure three times. A total of 27 tests were conducted (3 sensors x 3 modes x 3 repetitions). Each activity was recorded "complete," "partially complete," or "unable to complete." The investigators also recorded the time it took for each subject to complete each activity.

In the Year 2 study, the feasibility of the smart faucet was evaluated in each participant's residential bathroom. The goal was for participants to incorporate the faucet into their daily routines in a real-world setting. A total of 10 control participants without SCI and 7 individuals with SCI met the recruitment criteria, were enrolled, and completed the testing procedures. We conducted home visits for participants who met the recruitment criteria to assess whether the sink was suitable for faucet installation. If the sink was deemed suitable, written informed consent was obtained, and the faucet installation was scheduled. On the day of installation in each participant's bathroom, a licensed plumber installed the faucet. Following installation, a trained research associate performed testing and calibration of the device and provided instructions for trial preparation, including mobile app setup, usage, and operation of the faucet. The mobile app was used to automatically record user interactions and water flow settings. Each SCI participant then used the faucet for activities of daily living (ADLs) over a 14-day period, including drinking water (at least five times per day), face washing (morning and night), hand washing (morning and night), and hair washing (no set frequency). Participants were provided with a log sheet to record whether each activity was "complete" or "not complete." If an activity was skipped, participants were required to document the reason (e.g., "too difficult," "forgot," or "no need today"). On the 15th day of the trial, the plumber uninstalled the faucet, and the research associate collected the log sheet and a user-reported satisfaction survey.

Being tested
Water Faucet
Keywords
activities of daily living

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Water FaucetDevice

    Access H2OTM faucet is a smart, hand free faucet that is designed for ease water access for physical limitations

Study groups in NCT07062796
Study groupRoleWhat they receive
Faucet Water Output ActivationOtherYear 1 Study (in Clinic): Each subject was instructed to activate the water output modes for drinking and grooming using three different control methods of the faucet: placing their hand near the motion sensor (motion control), using a speech speaker (voice control), and using a remote sensor. For each activity of daily living (drinking and grooming), the physical therapist rated and recorded as "task completed", "partially completed", and "not completed." Year 2 study (at home): Each subject was instructed to activate the water output modes for drinking and grooming using three different control methods of the faucet: placing their hand near the motion sensor (motion control), using a speech speaker (voice control), and using a remote sensor. For each activity of daily living (drinking and grooming), the physical therapist rated and recorded as "task completed", "partially completed", and "not completed."
Receives: Device: Water Faucet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Water Output Mode Activation

    Each subject was measured to determine whether he or she can complete using the Access H2O faucet in clinic for drinking, grooming, and washing. Primary outcomes include "task completed", "task partially completed", and "not completed."

    Measured: 2 days

  2. Number of Participants with Water Output Mode Activation

    Each subject was measured to determine whether he or she can complete using the Access H2O faucet in the subject's residential bathroom for drinking, grooming, and washing. Primary outcomes include "task completed", "task partially completed", and "not completed."

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2025
  2. Study start3 Jun 2025
  3. Primary completion13 Apr 2026
  4. Study completion13 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07062796
Sponsor's protocol ID
R44HD108061
Other IDs
2R44HD108061-02
Status last verified
Jul 2025
First submitted
3 Jul 2025
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We don't plan to share individual participant raw data; however, aggregated and tabulated data will be published in peer-reviewed articles.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Water Faucet in people with Spinal Cord Injury Cervical, run by Old Dominion University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Water Output Mode Activation (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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