NCT06159946

Brief Summary

The Phase I SBIR objective is to design, develop \& demonstrate feasibility of Access-H2OTM, a sensor driven smart faucet to enable and empower independent drinking and grooming for individuals impacted by spinal cord injury (SCI). SCI severely impacts functional independence \& ability to perform activities of daily living (ADLs). Greater function is typically lost with higher, more complete injuries. More specifically, those impacted above C5-C7 have impaired upper extremities, which limits the use of arms and hands for activities such as eating, drinking, and grooming. Functional access to water for these individuals becomes a key to increased independence and successful completion of ADLs. Therefore, commercialization of smart fountain faucets, which can automatically deliver water in target temperature, force, \& nozzle setting for a specific ADL, has the potential to empower individuals with SCI for greater independence \& and improved quality of life. Subjects with SCI and controls were recruited to test the functionality of the faucet which includes eye gaze, voice, and motion sensors to control the water stream for drinking, rinsing, and grooming.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

June 1, 2026

Completed
Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

October 4, 2023

Results QC Date

August 21, 2024

Last Update Submit

May 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Water Access for Activities of Daily Living

    Each subject could complete the tasks: 1. Can the test participants use their voice to activate the faucet to drink water, rinse their mouths, and rinse a quarter-size area of soap, or rinse fully from their left and/or right cheeks? 2. Can the test participants use the eye gaze mode to activate the faucet to drink water, rinse their mouths, and rinse a quarter-size area of soap, or rinse fully from their left and/or right cheeks? 3. Can the test participants use the hand motion to activate the faucet to drink water, rinse their mouths, and rinse a quarter-size area of soap, or rinse fully from their left and/or right cheeks? Coding 1 was labeled as "complete," coding 2 as "partially complete," and coding 3 as "not completed." The "complete" means all the tasks to activate the faucet were completed; The "partially complete" means the faucet was activated, but some tasks were not completed; The "not completed" means the tasks were not completed to activate the faucet.

    The duration of time of assessment of the participant lasted for 2 to 3 hours.

Study Arms (1)

Spinal cord injury

EXPERIMENTAL

Each subject was asked to place their hand by the motion sensor (motion control), use a speech speaker (voice control), and then move their eyes up, down, left, and right to activate the eye gaze sensor (eye gaze control) to control water outputs for drinking, rinsing, and grooming. Each subject performed the same task/function three times.

Device: Access-H2O faucet

Interventions

The assigned invention was developed to test the feasibility of the prototype of the Access-H2O faucet by assessing whether subjects can activate the faucet to control water outputs via the motion sensor, eye gaze, and a speech speaker. To activate the faucet via the motion sensor, each subject was asked to place his or her hand near the motion sensor. To activate the faucet via the eye gaze, each subject was asked to look directly at the eye gaze sensor. To activate the faucet via the speech speaker, each subject was asked to speak to the speaker. Each subject performed the same function three times. The water from the faucet was used for drinking, rinsing, and grooming.

Spinal cord injury

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Quadriplegics with injuries above C7

You may not qualify if:

  • Subjects with cognitive deficits, serious mental health or medical conditions that would compromise subject safety or accurate user feedback will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ODU Monarch Physical Therapy Clinic

Norfolk, Virginia, 23509, United States

Location

Limitations and Caveats

The only limitation is that individuals with severe spinal cord injuries may not be able to bend over to reach the water. The arch of the water stream has been optimized to address this issue; however, it still has limitations regarding the distance and height of the stream, which must be balanced to prevent water from splashing out of the sink.

Results Point of Contact

Title
Steve Waddell
Organization
Nasoni Inc

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 4, 2023

First Posted

December 7, 2023

Study Start

August 15, 2022

Primary Completion

April 15, 2023

Study Completion

April 15, 2023

Last Updated

June 1, 2026

Results First Posted

June 1, 2026

Record last verified: 2026-05

Locations