Investigation into the sleep benefits to a Chronic Obstructive Pulmonary Disease (COPD) sufferer using the SoeMac™ micro air conditioner
| ISRCTN | ISRCTN57095969 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57095969 |
| Secondary identifying numbers | 179873 |
- Submission date
- 26/03/2015
- Registration date
- 10/04/2015
- Last edited
- 30/01/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name used to refer to a number of progressive devastating and debilitating lung diseases, which includes chronic bronchitis, emphysema and chronic obstructive airways disease. People that have COPD typically feel breathless after physical activity, have a persistent cough with phlegm and suffer frequently from chest infections. There is no cure for the condition, but making lifestyle changes (such as stopping smoking) and taking medications (inhalers and/or tablets) can alleviate symptoms. The SoeMac™ unit is a micro air conditioner designed for home use and is sold as an alternative therapy product to help improve the quality of life for people with breathing disorders and fatigue issues. Responses from users have been very positive, and we have noticed particular benefits for COPD sufferers and improved quality of sleep. We want to test whether the SoeMac™ unit will improve quality of sleep for COPD patients.
Who can participate?
COPD patients from the Rivergreen Medical Centre, Nottingham (UK).
What does the study involve?
Participants are randomly put into two groups: half will use the SoeMac™ unit and the other half will use a dummy unit. The study is run over an 8-week period. Simple, non-invasive measures are recorded at the clinic fortnightly during the course of the study. A questionnaire is also filled in at the start and at the end of the study.
What are the possible benefits and risks of participating?
If the results of this study are good we hope to progress to a bigger and more formal clinical trial at the Queen’s Medical Centre Campus in Nottingham.
Where is the study run from?
Rivergreen Medical Centre, Nottingham (UK)
When is the study starting and how long is it expected to run for?
May 2015 to July 2015
Who is funding the study?
SOE Health Ltd (UK)
Who is the main contact?
Mr Neil Stentiford
neils@soemac.com
Contact information
Public
42D Derby Road
Beeston, Nottingham
NG9 2TG
United Kingdom
 ORCID ID |
0000-0002-3755-5216 |
|---|---|
| Phone | +44 (0) 795 782 8891 |
| neils@soemac.com |
Scientific
Nottingham Trent University
Clifton Lane
Nottingham
NG1 4BU
United Kingdom
| Phone | +44 (0) 115 848 3362 |
|---|---|
| michael.johnson@ntu.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Investigation into the sleep benefits to a Chronic Obstructive Pulmonary Disease (COPD) sufferer using the SoeMac™ micro air conditioner: a randomised controlled trial |
| Study objectives | Using the SoeMac™ for 8 weeks leads to improved quality of sleep for sufferers of COPD. |
| Ethics approval(s) | The study has been submitted to IRAS for ethics approval reference number 15/LO/0750 - pending. |
| Health condition(s) or problem(s) studied | Quality of sleep of 24 COPD patients |
| Intervention | 24 volunteer COPD sufferers: 12 live/12 placebo. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Improved quality of sleep for COPD sufferers |
| Secondary outcome measures | Recorded fortnightly at clinic: 1. Recording blood pressure 2. Blood oxygen saturation (blood sats) 3. Forced Vital Capacity (FVC) 4. Forced Expiratory Volume in one second (FEV1) Recorded at start and end of trial at clinic: 5. St George's quality of life/sleep questionnaire |
| Overall study start date | 01/05/2015 |
| Completion date | 01/07/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 24 |
| Key inclusion criteria | 1. COPD 2. Volunteers attached to Rivergreen Medical Centre |
| Key exclusion criteria | 1. Non-COPD sufferers 2. Not attached to Rivergreen Medical Centre 3. Not adults |
| Date of first enrolment | 01/05/2015 |
| Date of final enrolment | 01/07/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nottingham
NG11 8AD
United Kingdom
Sponsor information
Industry
42D Derby Road
Beeston
Nottingham
NG9 2TG
United Kingdom
| Phone | +44 (0) 795 782 8891 |
|---|---|
| neils@soemac.com | |
| Website | www.soemac.com |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | We have given Dr Michael Johnson full authority to publish the results in a way that he deems suitable. |
| IPD sharing plan |
Editorial Notes
09/08/2017: No publications found in PubMed, verifying study status with principal investigator.
