The light module in the LumiMed Nasal Device contains a light-emitting diode that creates an array of red light between 650 and 690 nm, which emerges from the device through an optically clear cone that is inserted into the patient’s nasal cavity by themselves. Each patient was expected to operate the LumiMed Nasal Device until 12 to 24 J/cm2 (energy required to generate 650 nm of light to stimulate PBM) of light energy has been emitted from the instrument (10 total seconds per nostril), twice per day for 10 days.
After 10 days, patients were evaluated for symptom relief, device comfort and device ease of use. Total Nasal Symptom Score (TNSS) was used for evaluation. The TNSS has been validated and adapted in most European countries, Canada, and the USA. It assessed the severity of main symptoms of the 20 patients with AR. The sum of scores for each symptom category was calculated (lowest score possible: 0 to highest score possible: 9). The sum of TNSS scores for each symptom category was calculated (total possible scores per patient were 0–9). Rhinorrhea/nasal secretions, nasal congestion, and nasal itching/sneezing were evaluated on a scale of 0–3 (0 no symptoms, 1 mild symptoms, 2 moderate symptoms, 3 severe symptoms). Device comfort was evaluated on a scale of 0–3 (0 no discomfort, 1 mild discomfort, 2 moderate discomfort, 3 severe discomfort). Device ease of use was evaluated on a scale of 0–3 (0 very easy, 1 somewhat difficult, 2 difficult, 3 very difficult).
Patients
Patient 1 was a 15-year-old white female. She presented with symptoms of seasonal nasal congestion and runny nose in the spring. Her TNSS at baseline was 3 (rhinorhea: 1, nasal congestion: 2, nasal itching/sneezing: 0). After 10 days of treatment with LumiMed Nasal Device, her TNSS was 0 (rhinorhea: 0, nasal congestion: 0, nasal itching/sneezing: 0). Her device comfort score was 0. Her device ease of use score was 0.
Patient 2 was a 25-year-old white female. She presented with perennial nasal congestion predominantly in fall and winter “after the heat goes on in her house.” Her TNSS at baseline was 3 (rhinorhea: 0, nasal congestion: 3, nasal itching/sneezing: 0). After 10 days of treatment with LumiMed Nasal Device, her TNSS was 0 (rhinorhea: 0, nasal congestion: 0, nasal itching/sneezing: 0). Her device comfort score was 0. Her device ease of use score was 0.
Patient 3 was a 46-year-old white male. He presented with seasonal symptoms of sneezing, itchy nose, and mild nasal congestion. His TNSS at baseline was 4 (rhinorhea: 1, nasal congestion: 1, nasal itching/sneezing: 3). After 10 days of treatment with LumiMed Nasal Device, his TNSS was 1 (rhinorhea: 0, nasal congestion: 0, nasal itching/sneezing: 1). His device comfort score was 0. His device ease of use score was 0.
Patient 4 was a 75-year-old Iranian male. He presented with symptoms of perennial nasal congestion. His TNSS at baseline was 3 (rhinorhea: 0, nasal congestion: 3, nasal itching/sneezing: 0). After 10 days of treatment with LumiMed Nasal Device, his TNSS was 1 (rhinorhea: 0, nasal congestion: 1, nasal itching/sneezing: 0). His device comfort score was 1. His device ease of use score was 1.
Patient 5 was a 12-year-old white female. She presented with symptoms of itchy watery eyes and nose in early and late spring. Her TNSS at baseline was 4 (rhinorhea: 3, nasal congestion: 1, nasal itching/sneezing: 3). After 10 days of treatment with LumiMed Nasal Device, her TNSS was 1 (rhinorhea: 1, nasal congestion: 0, nasal itching/sneezing: 0). Her device comfort score was 0. Her device ease of use score was 0.
Patient 6 was a 32-year-old Black male. He presented with symptoms itchy eyes and nose and sneezing in the spring. His TNSS at baseline was 7 (rhinorhea: 3, nasal congestion: 1, nasal itching/sneezing: 3). After 10 days of treatment with LumiMed Nasal Device, his TNSS was 2 (rhinorhea: 0, nasal congestion: 1, nasal itching/sneezing: 1). His device comfort score was 0. His device ease of use score was 0.
Patient 7 was a 44-year-old white female. She presented with seasonal symptoms of nasal congestion, runny nose and itchy eyes. Her TNSS at baseline was 6 (rhinorhea: 2, nasal congestion: 2, nasal itching/sneezing: 2). After 10 days of treatment with LumiMed Nasal Device, her TNSS was 0 (rhinorhea: 0, nasal congestion: 0, nasal itching/sneezing: 0). Her device comfort score was 0. Her device ease of use score was 0.
Patient 8 was a 62-year-old white male. He presented with perennial symptoms of nasal congestion, which he said were “worse in the winter with his cat at home.” His TNSS at baseline was 4 (rhinorhea: 0, nasal congestion: 3, nasal itching/sneezing: 1). After 10 days of treatment with LumiMed Nasal Device, his TNSS was 1 (rhinorhea: 0, nasal congestion: 1, nasal itching/sneezing: 0). His device comfort score was 0. His device ease of use score was 0.
Patient 9 was a 41-year-old Black male. He presented with perennial symptoms of nasal congestion and postnasal drip. His TNSS at baseline was 3 (rhinorhea: 0, nasal congestion: 3, nasal itching/sneezing: 0). After 10 days of treatment with LumiMed Nasal Device, his TNSS was 0 (rhinorhea: 0; nasal congestion: 0; nasal itching/sneezing: 0). His device comfort score was 0. His device ease of use score was 0).
Patient 10 was a 22-year-old white female. She presented with seasonal symptoms of itchy, watery eyes, runny nose, which she said were “worse in spring and late fall.” Her TNSS at baseline was 7 (rhinorhea: 3, nasal congestion: 1, nasal itching/sneezing: 3). After 10 days of treatment with LumiMed Nasal Device, her TNSS was 2 (rhinorhea: 1, nasal congestion: 0, nasal itching/sneezing: 1). Her device comfort score was 0. Her device ease of use score 0.
Patient 11 was a 19-year-old Black female. She presented with seasonal symptoms of nasal congestion in late spring and early fall. Her TNSS at baseline was 3 (rhinorhea: 0, nasal congestion: 3, nasal itching/sneezing: 0). After 10 days of treatment with LumiMed Nasal Device, her TNSS was 0 (rhinorhea: 0, nasal congestion: 0, nasal itching/sneezing: 0). Her device comfort score was 0. Her device ease of use score was 0.
Patient 12 was a 10-year-old Oriental female. She presented with symptoms of chronic nasal congestion “with 2 cats at home.” Her TNSS at baseline was 3 (rhinorhea: 0, nasal congestion: 3, nasal itching/sneezing: 0). After 10 days of treatment with LumiMed Nasal Device, her TNSS was 1 (rhinorhea: 0, nasal congestion: 1, nasal itching/sneezing: 0). Her device comfort score was 0. Her device ease of use score was 0.
Patient 13 was a 25-year-old Black male. He presented with seasonal sneezing, watery nasal discharge in the spring. His TNSS at baseline was 6 (rhinorhea: 3, nasal congestion: 0, nasal itching/sneezing: 3). After 10 days of treatment with LumiMed Nasal Device, his TNSS was 2 (rhinorhea: 1, nasal congestion: 0, nasal itching/sneezing: 1). His device comfort score was 0. His device ease of use score was 0.
Patient 14 was an 11-year-old Oriental male. He presented with symptoms of perennial nasal congestion, “worse in the fall and winter.” His TNSS at baseline was 3 (rhinorhea: 0, nasal congestion: 3, nasal itching/sneezing: 0). After 10 days of treatment with LumiMed Nasal Device, his TNSS was 0 (rhinorhea: 0, nasal congestion: 0, nasal itching/sneezing: 0). His device comfort score was 0. His device ease of use score was 1.
Patient 15 was a 47-year-old white female. She presented with symptoms of nasal congestion and clear nasal discharge in early fall. Her TNSS at baseline was 4 (rhinorhea: 2, nasal congestion: 2, nasal itching/sneezing: 0). After 10 days of treatment with LumiMed Nasal Device, her TNSS was 1 (rhinorhea: 0, nasal congestion: 0, nasal itching/sneezing: 1). Her device comfort score was 0. Her device ease of use score was 0.
Patient 16 was a 59-year-old Black male. He presented with severe itchy watery eyes and nose with sneezing in spring. His TNSS at baseline was 7 (rhinorhea: 3, nasal congestion: 1, nasal itching/sneezing: 3). After 10 days of treatment with LumiMed Nasal Device, his TNSS was 1 (rhinorhea: 1, nasal congestion: 0, nasal itching/sneezing: 0). His device comfort score was 0. His device ease of use score was 0.
Patient 17 was a 65-year-old Black female. She presented with perennial nasal congestion that was “worse in the fall and winter.” Her TNSS at baseline was 3 (rhinorhea: 0, nasal congestion: 3, nasal itching/sneezing: 0). After 10 days of treatment with LumiMed Nasal Device, her TNSS was 0 (rhinorhea: 0, nasal congestion: 0, nasal itching/sneezing: 0). Her device comfort score was 0. Her device ease of use score was 1.
Patient 18 was a 37-year-old white female. She presented with itchy, watery eyes and nose in the spring and fall, but was “worse in the spring.” Her TNSS at baseline was 5 (rhinorhea: 2, nasal congestion: 1, nasal itching/sneezing: 2). After 10 days of treatment with LumiMed Nasal Device, her TNSS was 1 (rhinorhea: 0, nasal congestion: 0, nasal itching/sneezing: 1). Her device comfort score was 0. Her device ease of use score was 0.
Patient 19 was a 37-year-old white male. He presented with seasonal nasal congestion with sneezing, clear nasal discharge, and mild nasal congestion. His TNSS at baseline was 6 (rhinorhea: 3, nasal congestion: 1, nasal itching/sneezing: 2). After 10 days of treatment with LumiMed Nasal Device, his TNSS was 1 (rhinorhea: 1, nasal congestion: 0, nasal itching/sneezing: 0). His device comfort score was 0. His device ease of use score was 0.
Patient 20 was a 16-year-old white female. She presented with a watery, itchy nose in the spring. Her TNSS at baseline was 6 (rhinorhea: 3, nasal congestion: 0, nasal itching/sneezing: 3). After 10 days of treatment with LumiMed Nasal Device, her TNSS was 0 (rhinorhea: 0, nasal congestion: 0, nasal itching/sneezing: 0). Her device comfort score was 0. Her device ease of use score was 0.
The average baseline TNSS for the 20 patients in this case study was 4.7 and was reduced to 0.75 after 10 days of treatment with LumiMed Nasal Device (Tables
1 and
2). The results from these case studies indicated that of the 20 patients in this case study, 100% of patients experienced improvement in overall TNSS after using LumiMed Nasal Device. Of those patients, 40% brought their TNSS down to 0. Furthermore, 95% felt the LumiMed Nasal Device was comfortable to use, while 85% of patients felt the LumiMed Nasal Device was easy to use (Table
3).
Table 2
Patient scores 10 days post-treatment
1 | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 0 | 0 |
3 | 0 | 0 | 1 | 1 |
4 | 0 | 1 | 0 | 1 |
5 | 1 | 0 | 0 | 1 |
6 | 0 | 1 | 1 | 2 |
7 | 0 | 0 | 0 | 0 |
8 | 0 | 1 | 0 | 1 |
9 | 0 | 0 | 0 | 0 |
10 | 1 | 0 | 1 | 2 |
11 | 0 | 0 | 0 | 0 |
12 | 0 | 1 | 0 | 1 |
13 | 1 | 0 | 1 | 2 |
14 | 0 | 0 | 0 | 0 |
15 | 0 | 0 | 1 | 1 |
16 | 1 | 0 | 0 | 1 |
17 | 0 | 0 | 0 | 0 |
18 | 0 | 0 | 1 | 1 |
19 | 1 | 0 | 0 | 1 |
20 | 0 | 0 | 0 | 0 |
Table 3
Patient-reported comfort and ease of use of LumiMed device
1 | 0 | 0 |
2 | 0 | 0 |
3 | 0 | 0 |
4 | 1 | 1 |
5 | 0 | 0 |
6 | 0 | 0 |
7 | 0 | 0 |
8 | 0 | 0 |
9 | 0 | 0 |
10 | 0 | 0 |
11 | 0 | 0 |
12 | 0 | 0 |
13 | 0 | 0 |
14 | 0 | 1 |
15 | 0 | 0 |
16 | 0 | 0 |
17 | 0 | 1 |
18 | 0 | 0 |
19 | 0 | 0 |
20 | 0 | 0 |