Health Condition 1: R065- Mouth breathing
Conditions
Interventions
None listed
Sponsors
GIOSUN HEALTHCARE PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 12 and 65 years, inclusive, at the time of screening, having a regular bed partner or co-sleeper who is willing and able to complete snoring-related assessments throughout the study duration. 2. Self-reported habitual snoring, defined as snoring occurring greater than equal to 3 nights per week, as reported by the participant and or their co-sleeper. 3. Willing and able to provide written informed consent (or assent, where applicable, along with parental or legal guardian consent for minors). 4. AV consent is mandatory for adolescents (aged below 18 years) and geriatric population (60 years and above). 5. Willing to comply with all study procedures and attend scheduled visits. 6. For minors (participants under 18 years of age)- A parent or legal guardian must also be willing to comply with study protocol requirements and provide consent on behalf of the child.
Exclusion criteria
Exclusion criteria: 1. Current or past diagnosis of Obstructive Sleep Apnea (OSA) or use of CPAP or BiPAP therapy. 2. History of nasal obstruction, nasal surgery, or structural abnormalities likely to influence airflow (e.g., deviated nasal septum, nasal polyps). 3. Pregnant or lactating females. 4. Participation in another clinical drug trial within the last 3 months prior to screening. 5. Use of any study drug or treatment within 3 months prior to enrollment. 6. Known or suspected alcohol or substance abuse currently or within the past 24 weeks. 7. Any medical or psychiatric condition, or use of medications, that in the opinion of the Investigator may interfere with study participation or confound study results. 8. Participant/Co-sleeper unwilling or unable to comply with the requirements of the Protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in snoring frequency and intensity from Baseline to Day 30 as measured using the partner-reported Visual Analogue Scale. 2. Change in snoring severity and risk category from Baseline to Day 30 as assessed using the Berlin Questionnaire.Timepoint: Day 0, Day 15 2, Day 30 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Health-Related Quality of Life (HRQoL) from Baseline to Day 30 as measured by the Short Form-36 (SF-36) Health Survey.Timepoint: Day 0, Day 15 2, Day 30 2 | — |
Countries
India
Contacts
Public ContactMs Arpita Malgi
Samahitha Research Solutions
Outcome results
None listed