Condition category
Respiratory
Date applied
26/03/2015
Date assigned
10/04/2015
Last edited
14/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Mr Neil Stentiford

ORCID ID

http://orcid.org/0000-0002-3755-5216

Contact details

42D Derby Road
Beeston
Nottingham
NG9 2TG
United Kingdom
+44 (0) 795 782 8891
neils@soemac.com

Type

Scientific

Additional contact

Dr Michael Johnson

ORCID ID

Contact details

Nottingham Trent University
Clifton Lane
Nottingham
NG1 4BU
United Kingdom
+44 (0) 115 848 3362
michael.johnson@ntu.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

179873

Study information

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

Acronym

Study hypothesis

Using the SoeMac™ for 8 weeks leads to improved quality of sleep for sufferers of COPD.

Ethics approval

The study has been submitted to IRAS for ethics approval reference number 15/LO/0750 - pending.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Quality of sleep of 24 COPD patients

Intervention

24 volunteer COPD sufferers: 12 live/12 placebo.

Intervention type

Device

Phase

Drug names

Primary outcome measures

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 trial start date

01/05/2015

Overall trial end date

01/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. COPD
2. Volunteers attached to Rivergreen Medical Centre

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. Non-COPD sufferers
2. Not attached to Rivergreen Medical Centre
3. Not adults

Recruitment start date

01/05/2015

Recruitment end date

01/07/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Rivergreen Medical Centre
106 Southchurch Drive, Clifton
Nottingham
NG11 8AD
United Kingdom

Sponsor information

Organisation

SOE Health Ltd

Sponsor details

42D Derby Road
Beeston
Nottingham
NG9 2TG
United Kingdom
+44 (0) 795 782 8891
neils@soemac.com

Sponsor type

Industry

Website

www.soemac.com

Funders

Funder type

Not defined

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We have given Dr Michael Johnson full authority to publish the results in a way that he deems suitable.

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes