Xerostomia
Conditions
Brief summary
This Human Factors Validation Testing will assess user interactions to verify the capability of potential users to assess if the study product fits their needs and if they can use it correctly based on the provided Information For User (IFU)? More specifically, this is a non-comparative case series study and is subdivided into two major parts. Those parts are: 1. Phase I: aimed at testing if, based on the IFU, the potential subjects can decide whether the study product is or is not appropriate to treat their condition and, 2. Phase II: aimed at assessing whether the users can use the study product correctly without counseling by a health care provider.
Detailed description
Phase I To simulate an OTC setting, potential subjects will be requested to read the label text on the outside of the study product package (external labeling) and determine whether the study product addresses their needs, without a provider direction or assistance. Phase II The study product will be dispensed only to those subjects who will indicate that they voluntarize to participate in this phase of the study. At Phase II subjects with xerostomia and that are willing to try the study product, will be requested to use it with no training, except for their understanding of the User Manual (internal labeling). Those subjects will use the study product in a supervised clinical setting. Subjects who report any discomfort will be offered the option to pause and remove the device upon such a request. Correct use verification will be performed by the study investigators. Subjects will answer questions regarding product use, clarity of the IFU, ease of use, etc. Subjects will also receive an exam of their oral cavity.
Interventions
DEVICEElectrical salivary stimulator system assigned to subjects with xerostomia
SaliPen is an electrical salivary stimulator system, intended to electrically stimulate a relative increase in saliva production. It is an intraoral device indicated for use in patients with xerostomia (dry mouth).
DEVICENo Electrical salivary stimulator system assigned to subjects without xerostomia
SaliPen is an electrical salivary stimulator system, intended to electrically stimulate a relative increase in saliva production. It is an intraoral device indicated for use in patients with xerostomia (dry mouth).
Sponsors
Indiana University
Saliwell Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single-center, prospective, open-label study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
For Phase I: 8 subjects with xerostomia and 8 without that are 18 years old or older For Phase II: Subjects with xerostomia that are 18 years old or older
Exclusion criteria
For Phase I: * Children and adolescents (persons under 18 years of age) * Persons with experience in the use of SaliPen For Phase II: Subjects for them the study product is not indicated and/or do not agree to participate in Phase II. For the avoidance of doubt, the following conditions are
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Appropriately Will Self-select the Study Product for Use Under Simulated OTC Conditions [Phase I] | One hour | Following the standard norms for the Rx-to-OTC switch process, this outcome is a validation of potential consumers' ability to self-diagnose the condition and to decide that treatment with the product is appropriate for them. |
| Percentage of Participants Who Correctly Will Use the Study Product When Dispensed Under Simulated OTC Conditions [Phase II]. | 1.5 hour | Correct use means that the participants will demonstrate the use of the study product according to the guidelines outlined in the User Manual. Following the standard norms for the therapy of Rx-to-OTC switch process, this outcome is a validation of potential consumers' ability to self-treat with the product according to the product's supplied IFU. |
Countries
United States
Participant flow
Recruitment details
Patients visiting the participating clinic were asked to participate in the study sequentially (by order of recall or arrival at the clinic). For Phase I, enrollment was stopped once the goal of eight (8) subjects with xerostomia and eight (8) subjects without xerostomia has been reached. For Phase II, 16 subjects with xerostomia that were evaluated or treated at the clinic were enrolled sequentially (by order of recall or arrival at the clinic).
Pre-assignment details
Period 1 was devoted to Phase I that included 8 subjects with and 8 without xerostomia. Period 2 was devoted to Phase II that included 16 subjects with xerostomia. Eight of those participated previously in Phase II.
Participants by arm
| Arm | Count |
|---|---|
| Selection and/or Use of the SaliPen Device by Subjects With or Without Xerostomia Phase I Subjects with and without xerostomia were requested to read the label text on the outside of the study product package (external labeling) and determine whether the study product addresses their needs, without a provider direction or assistance.
Phase II The study product was dispensed only to subjects with xerostomia. They were requested to use it with no training, except for their understanding of the User Manual (internal labeling). Those subjects used the study product in a supervised clinical setting. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Selection and/or Use of the SaliPen Device by Subjects With or Without Xerostomia |
|---|---|
| Age, Categorical Phase II subjects with xerostomia <=18 years | 0 Participants |
| Age, Categorical Phase II subjects with xerostomia >=65 years | 3 Participants |
| Age, Categorical Phase II subjects with xerostomia Between 18 and 65 years | 13 Participants |
| Age, Categorical Phase I subjects without xerostomia <=18 years | 0 Participants |
| Age, Categorical Phase I subjects without xerostomia >=65 years | 1 Participants |
| Age, Categorical Phase I subjects without xerostomia Between 18 and 65 years | 7 Participants |
| Age, Categorical Phase I subjects with xerostomia <=18 years | 0 Participants |
| Age, Categorical Phase I subjects with xerostomia >=65 years | 3 Participants |
| Age, Categorical Phase I subjects with xerostomia Between 18 and 65 years | 5 Participants |
| Age, Continuous Phase II subjects with xerostomia | 53 years |
| Age, Continuous Phase I subjects without xerostomia | 47 years |
| Age, Continuous Phase I subjects with xerostomia | 58 years |
| Race (NIH/OMB) Phase II subjects with xerostomia American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Phase II subjects with xerostomia Asian | 0 Participants |
| Race (NIH/OMB) Phase II subjects with xerostomia Black or African American | 0 Participants |
| Race (NIH/OMB) Phase II subjects with xerostomia More than one race | 2 Participants |
| Race (NIH/OMB) Phase II subjects with xerostomia Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Phase II subjects with xerostomia Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Phase II subjects with xerostomia White | 14 Participants |
| Race (NIH/OMB) Phase I subjects without xerostomia American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Phase I subjects without xerostomia Asian | 4 Participants |
| Race (NIH/OMB) Phase I subjects without xerostomia Black or African American | 1 Participants |
| Race (NIH/OMB) Phase I subjects without xerostomia More than one race | 0 Participants |
| Race (NIH/OMB) Phase I subjects without xerostomia Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Phase I subjects without xerostomia Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Phase I subjects without xerostomia White | 3 Participants |
| Race (NIH/OMB) Phase I subjects with xerostomia American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Phase I subjects with xerostomia Asian | 0 Participants |
| Race (NIH/OMB) Phase I subjects with xerostomia Black or African American | 0 Participants |
| Race (NIH/OMB) Phase I subjects with xerostomia More than one race | 1 Participants |
| Race (NIH/OMB) Phase I subjects with xerostomia Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Phase I subjects with xerostomia Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Phase I subjects with xerostomia White | 7 Participants |
| Sex: Female, Male Phase II subjects with xerostomia Female | 14 Participants |
| Sex: Female, Male Phase II subjects with xerostomia Male | 2 Participants |
| Sex: Female, Male Phase I subjects without xerostomia Female | 4 Participants |
| Sex: Female, Male Phase I subjects without xerostomia Male | 4 Participants |
| Sex: Female, Male Phase I subjects with xerostomia Female | 6 Participants |
| Sex: Female, Male Phase I subjects with xerostomia Male | 2 Participants |
| Xerostomia status based on self-report (suffering or not from xerostomia) Phase II subjects with xerostomia | 16 Participants |
| Xerostomia status based on self-report (suffering or not from xerostomia) Phase I subjects without xerostomia | 8 Participants |
| Xerostomia status based on self-report (suffering or not from xerostomia) Phase I subjects with xerostomia | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Percentage of Participants Who Appropriately Will Self-select the Study Product for Use Under Simulated OTC Conditions [Phase I]
Following the standard norms for the Rx-to-OTC switch process, this outcome is a validation of potential consumers' ability to self-diagnose the condition and to decide that treatment with the product is appropriate for them.
Time frame: One hour
Population: Eight subjects with xerostomia and 8 subjects without xerostomia
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: Use of SaliPen Medical Device | Percentage of Participants Who Appropriately Will Self-select the Study Product for Use Under Simulated OTC Conditions [Phase I] | Percentage of correct answers to the question on eligibility to use the SaliPen device | 100 percentage |
| Experimental: Use of SaliPen Medical Device | Percentage of Participants Who Appropriately Will Self-select the Study Product for Use Under Simulated OTC Conditions [Phase I] | Percentage of patients providing correct answers | 100 percentage |
Primary
Percentage of Participants Who Correctly Will Use the Study Product When Dispensed Under Simulated OTC Conditions [Phase II].
Correct use means that the participants will demonstrate the use of the study product according to the guidelines outlined in the User Manual. Following the standard norms for the therapy of Rx-to-OTC switch process, this outcome is a validation of potential consumers' ability to self-treat with the product according to the product's supplied IFU.
Time frame: 1.5 hour
Population: All patients suffered from xerostomia
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: Use of SaliPen Medical Device | Percentage of Participants Who Correctly Will Use the Study Product When Dispensed Under Simulated OTC Conditions [Phase II]. | Percentage of correct performances | 100 percentage |
| Experimental: Use of SaliPen Medical Device | Percentage of Participants Who Correctly Will Use the Study Product When Dispensed Under Simulated OTC Conditions [Phase II]. | Percentage of subjects performing correctly | 100 percentage |