Subjects With Clinical Diagnosis of Allergic Rhinitis Were Randomly Divided Into 2 Groups, With Patients in One Group Given One Treatment Session of Red Light Rhinophototherapy, Followed by Medical Treatment. Those in the Second Group Were Treated With Medical Treatment Only.

NCT03752645 | Completed

• 1 other identifier: CF18014A#1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the short-term effects of red light rhinophototherapy on nasal patency in patients with a clinical diagnosis of allergic rhinitis using both active anterior rhinomanometry and acoustic rhinometry.

Conditions

Allergic Rhinitis; Phototherapy

Keywords

acoustic rhinometry; active anterior rhinomanometry; allergic rhinitis; red light rhinophototherapy

Outcome Measures

Primary Outcomes (2)

• Change from baseline in nasal resistance and nasal flow after red light Change from baseline in nasal resistance and nasal flow after red light rhinophototherapy

  To compare the change from baseline in nasal resistance and nasal flow 30 minutes after red light rhinophototherapy by using active anterior rhinomanometry

  before and 30 minutes after red light rhinophototherapy

• Change from baseline in the first and second minimal cross sectional area, and the volumes between the tip and 3.0 cm from the tip of the nosepiece and between 2.0 and 5.0 cm from the tip of the nosepiece after red light rhinophototherapy

  To compare the change from baseline in the first minimal cross sectional area of the nasal cavity, the second minimal cross sectional area of the nasal cavity, the nasal volume between the tip of the nosepiece and 3.0 cm into the nasal cavity, and the nasal volume of the nasal cavity between 2.0 and 5.0 cm from the tip of the nosepiece 30 minutes after red light rhinophototherapy by using acoustic rhinometry

  before and 30 minutes after red light rhinophototherapy

Secondary Outcomes (1)

• rhinitis symptoms

  before red light rhinophototherapy, and 30 minutes and 2 days after red light rhinophototherapy

Study Arms (2)

intervention

EXPERIMENTAL

Transverse Many Channels Laser Instrument

Device: Transverse Many Channels Laser Instrument

control

NO INTERVENTION

Interventions

Transverse Many Channels Laser Instrument DEVICE

The device consists of a control box and 4 sets of two light-emitting nasal probes. Prior to treatment, each patient put on a pair of black tinted glasses, and had the nasal probes gently placed into both nostrils. A turn-on switch on the control box activated the probe and the timer was set at 15 minutes during which time 36 J of light energy was delivered to each nostril.

intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients experiencing moderate to severe symptoms of allergic rhinitis
• Patients possessing at least one of the following symptoms: nasal congestion, runny nose, itchy nose, or sneezing
• Patients whose physical examination showing clear rhinorrhea, nasal congestion, pale discoloration of the nasal mucosa, or red and watery eyes

You may not qualify if:

• Patients with age below 20 years old
• Patients with severe nasal septum, rhinosinusitis and nasal polyposis
• Patients who had a history of immunodeficiency or previous sinus surgery
• Patients who suffered from an upper respiratory tract infection
• Patients who took oral corticosteroids within a month prior to the study

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Related Publications (1)

• Jiang RS, Wang JJ. Effect of Red Light Rhinophototherapy on Nasal Patency in Patients with Allergic Rhinitis. Int J Otolaryngol. 2018 Dec 17;2018:6270614. doi: 10.1155/2018/6270614. eCollection 2018.

  PMID: 30647740 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Rong-San Jiang, MD, PhD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2018
• First Posted: November 26, 2018
• Study Start: March 2, 2018
• Primary Completion: June 27, 2018
• Study Completion: June 30, 2018
• Last Updated: November 26, 2018

Record last verified: 2018-11

Locations

TW (1)