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Status unknownNCT03295019Updated Jan 9, 2019

"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients

An interventional study of Test Oral Spray and Placebo Oral Spray in Dry Mouth, Xerostomia and OSA, sponsored by You First Services. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by You First Services · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Dry Mouth
  • Xerostomia
  • OSA
  • Sleep Apnea
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient should be above 18 years of age.
  2. 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.
  3. Ability to attend visits at the research site
  4. Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study
  5. Have a negative history of radiation therapy to head and neck
  6. Agree to abstain from the use of any products for xerostomia other than those provided in the study.
  7. Agree to comply with the conditions and schedule of the study.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with open mouth sores at study entry.
  2. Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia (immune disorders, etc.)
  3. Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period
  4. Subjects currently on medication or treatment for dry mouth/xerostomia
  5. Subjects \< 18 years of age
  6. Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.
  7. Subjects with soft or hard tissue tumor of the oral cavity.
  8. Presence of severe gingivitis
  9. Chronic disease with concomitant oral manifestations other than xerostomia
  10. Subjects with conditions the investigator may feel will interfere with the condition under study.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Test Oral Spray

    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.

    Device: Test Oral Spray

  • Placebo comparator
    Placebo Oral Spray

    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.

    Device: Placebo Oral Spray

Interventions

  • DeviceTest Oral Spray

    HA formulation of FDA listed ingredients

  • DevicePlacebo Oral Spray

    Placebo formulation without the active ingredients

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 9 weeks

06

Study locations

1 of 1 sites recruiting
  • VA WNY Healthcare System
    Buffalo, New York 14215, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT03295019
Lead sponsor
You First Services
Responsible party
Sponsor
First posted
Sep 27, 2017
Start date
Aug 4, 2017
Primary completion
Jun 30, 2019 (estimated)
Completion
Jul 31, 2019 (estimated)
Last update
Jan 9, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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