Testing the safety and efficacy of the SoeMac device for COPD patients
Research type
Research Study
Full title
A study to test the safety and efficacy of singlet oxygen energy delivered via the SoeMac device in people living with Chronic Obstructive Pulmonary Disease (COPD).
IRAS ID
280361
Contact name
Milind Sovani
Contact email
Sponsor organisation
Research & Innovation
Duration of Study in the UK
1 years, 0 months, 25 days
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is a progressive and debilitating obstructive lung disorder which limits airflow and reduces lung function with symptoms including breathlessness, coughing and sleep disturbance. COPD patients commonly experience breathlessness which reduces the ability to exercise and undertake day-to-day activities. In addition, sleep disturbance including trouble falling and staying asleep and waking up feeling tired also affects their quality of life.
COPD affects around 1.2 million people at a cost to the NHS of approximately £1.9bn each year. In addition, COPD exacerbations leading to hospital admission costs the NHS an average of £3,726 per episode, therefore interventions that could help to reduce these hospitalisations are highly desirable.
The aim of this randomised controlled study is to evaluate whether the SoeMac device is safe and can improve the health and quality of life of patients with COPD. The SoeMac device generates single oxygen energy (SOE) by the action of red light on a chemical photosensitizer. The energised air is expelled from the device and breathed in by the user, usually overnight. Previous research has shown that SOE can have beneficial biological effects and indicates that people with respiratory conditions, such as COPD, perceive benefit from using the SoeMac including reduced breathlessness, improved sleep and increased energy levels.
The study will recruit patients with COPD from both GP surgeries and community patient support groups (Breathe Easy Groups). The patients will be randomised to receive either a SoeMac device or an inactive “placebo” device which will be used every night for 12 weeks. Safety and side effects/adverse events will be recorded and patient will complete questionnaires to assess breathlessness, sleep and activities of daily living.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0255
Date of REC Opinion
2 Dec 2021
REC opinion
Further Information Favourable Opinion