Study on the efficacy of LED phototherapy in patients with seasonal allergic rhinitis

JRCT ID: jRCTs032220525

Registered date:22/12/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: seasonal allergic rhinitis
• Date of first enrollment: 25/01/2023
• Target sample size: 22
• Study type: Interventional
• Intervention(s): Subjects will be irradiated with red light (660nm) and near-infrared light (940nm) from an LED light source using a low-power light irradiator (product name: LumiTherapy Nose Care, model name: LN-01W, LN-01A, Double H Co., Ltd.; hereafter Nose Care) three times a day (morning, noon and night, each time for about three minutes) for one month (four weeks).

Outcome(s)

• Primary Outcome: - Amount of change in allergic rhinitis severity score (sneezing attacks, nasal discharge, nasal obstruction, itchy nose)

Secondary Outcome

- Rate of adverse events
- Amount of change in QOL score in allergic rhinitis assessed by the Japanese version of Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ) (No. 1)
- Amount of change in sleep quality score evaluated by the Pittsburgh Sleep Questionnaire (Pittsburgh Sleep Questionnaire)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 50age old
• Gender: Both

Include criteria

1) Men and women between the ages of 18 and 50 years old at the time of informed consent
2) Patients diagnosed with allergic rhinitis
3) Patients with cedar-specific IgE antibodies
4) Patients who have start the treatment of allergic rhinitis
5) Patients who are able to visit Juntendo Hospital or Hongo Otorhinolaryngology Clinic
6) Patients who have given a full explanation of their participation in this study and who have given written consent of their own free will.

Exclude criteria

1) Patients undergoing treatment for or with a history of peripheral neuropathy or photosensitivity
2) Patients who are being treated for or have a history of mental illness, stroke, or myocardial infarction
3) Patients who are pregnant or planning to become pregnant during the study period
4) Patients who are using steroids (oral or injectable) or biological agents for the treatment of allergic rhinits
5) Patients who started taking allergic rhinitis medication or who have changed or added to their medication within 4 weeks prior to the start of the intervention.
6) Any other Patients who is deemed by the physician to be ineligible to participate in the study.

Related Information

• Primary Sponsor: Tanigawa Takeshi