Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion (SCORE)

Third Wave Therapeutics

Status: Completed

Conditions: Nasal Congestion and Inflammations

Treatments: Device: Sonu

Study type: Interventional

Funder types: Industry

Identifiers

NCT05821842

CP-002

Details and patient eligibility

About

To demonstrate the safety and effectiveness of Sonu for the treatment of patients suffering from moderate to severe nasal congestion.

Full description

Sonu consists of and acoustic vibrational headband worn circumferentially at the level of the forehead. A smart phone App, paired to the headband, delivers acoustic resonant frequencies of the subject's nasal cavity through the headband and provides relief. Sonu is intended to be used for the treatment of moderate to severe nasal congestion due to rhinitis.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age and older
• Present with symptoms of nasal congestion for 1 month or more prior to treatment
• Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening

Exclusion criteria

• Head, nasal or sinus surgery within 3 months
• Sinus infection diagnosed within the last month, or rhinitis medicamentosa
• Documented history of nasal polyposis or mass

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Sonu Treatment Group

Experimental group

Description:

Patients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu.

Treatment:

Device: Sonu

Sham Control Group

Sham Comparator group

Description:

Patients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu.

Treatment:

Device: Sonu