Dry MouthNCT03295019
"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients
A study testing Test Oral Spray in people with Dry Mouth and Xerostomia, run by You First Services at 1 site in United States.
Trial summary
During routine clinical practice, it is observed that patients with suspected obstructive sleep apnea (OSA) often reported waking up with a dry mouth during the night or in the morning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Mouth, Xerostomia, OSA
- What is being tested?
- Test Oral Spray
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2017to 31 Jul 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient should be above 18 years of age.
- Patients who have been initiated on CPAP therapy after an initial diagnosis of OSAS and have developed dry mouth or have worsening of pre-existing dry mouth condition, as an effect of CPAP therapy.
- Ability to attend visits at the research site
- Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study
- Have a negative history of radiation therapy to head and neck
- Agree to abstain from the use of any products for xerostomia other than those provided in the study.
- Agree to comply with the conditions and schedule of the study.
Who cannot join
- Subjects with open mouth sores at study entry.
- Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia (immune disorders, etc.)
- Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period
- Subjects currently on medication or treatment for dry mouth/xerostomia
- Subjects < 18 years of age
- Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.
Show all 10Show fewer
- Subjects with soft or hard tissue tumor of the oral cavity.
- Presence of severe gingivitis
- Chronic disease with concomitant oral manifestations other than xerostomia
- Subjects with conditions the investigator may feel will interfere with the condition under study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA WNY Healthcare System
Buffalo, New York, 14215
Archana Mishra, MD, 716-834-9200, Archana.Mishra@va.gov
About this study
Official title: Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients.
During routine clinical practice, it is observed that patients with suspected obstructive sleep apnea (OSA) often reported waking up with a dry mouth during the night or in the morning. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of a proprietary formulation in comforting dry mouth in Sleep Apnea patients.
- Conditions
- Dry Mouth, Xerostomia, OSA, Sleep Apnea
- Being tested
- Test Oral Spray, Placebo Oral Spray
- Medical subject headings
- Xerostomia, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Oral SprayDevice
HA formulation of FDA listed ingredients
Placebo Oral SprayDevice
Placebo formulation without the active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Test Oral Spray | Experimental | Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study. Receives: Device: Test Oral Spray |
| Placebo Oral Spray | Placebo comparator | Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their placebo mouth spray, 2 times daily (morning and evening), for the 4 week duration of the study. Receives: Device: Placebo Oral Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief from dry mouth survey using questionnaires.
Evaluate patients' perception of efficacy of a new mouth spray compared to a placebo in reducing the symptoms of dry mouth in Sleep Apnea patients. Survey will be done by distributing diaries with daily, weekly and end of study questionnaires.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start4 Aug 2017
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry MouthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- You First Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295019
- Sponsor's protocol ID
- LUA-102-16
- Status last verified
- Jan 2019
- First submitted
- 21 Sep 2017
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients.
- ClinicalTrials.gov ID
- NCT03295019
- Acronym / sponsor ID
- LUA-102-16
- Conditions
- Dry Mouth, Xerostomia, OSA, Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- You First ServicesIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 27 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During routine clinical practice, it is observed that patients with suspected obstructive sleep apnea (OSA) often reported waking up with a dry mouth during the night or in the morning. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of a proprietary formulation in comforting dry mouth in Sleep Apnea patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Oral Spray | Experimental | Device: Test Oral SpraySubjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study. |
| Placebo Oral Spray | Placebo comparator | Device: Placebo Oral SpraySubjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their placebo mouth spray, 2 times daily (morning and evening), for the 4 week duration of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient should be above 18 years of age.
- Patients who have been initiated on CPAP therapy after an initial diagnosis of OSAS and have developed dry mouth or have worsening of pre-existing dry mouth condition, as an effect of CPAP therapy.
- Ability to attend visits at the research site
- Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study
- Have a negative history of radiation therapy to head and neck
Key exclusion criteria (10 listed)
- Subjects with open mouth sores at study entry.
- Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia (immune disorders, etc.)
- Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period
- Subjects currently on medication or treatment for dry mouth/xerostomia
- Subjects < 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test Oral SprayHA formulation of FDA listed ingredients | Device | Test Oral Spray |
| Placebo Oral SprayPlacebo formulation without the active ingredients | Device | Placebo Oral Spray |
Primary outcome
Relief from dry mouth survey using questionnaires.
Time frame: 9 weeks
Evaluate patients' perception of efficacy of a new mouth spray compared to a placebo in reducing the symptoms of dry mouth in Sleep Apnea patients. Survey will be done by distributing diaries with daily, weekly and end of study questionnaires.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Oral Spray in people with Dry Mouth and Xerostomia, run by You First Services 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 9 Jan 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief from dry mouth survey using questionnaires. (time frame: 9 weeks). 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 9 Jan 2019.