Condition category
Nervous System Diseases
Date applied
17/05/2012
Date assigned
28/05/2012
Last edited
05/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Obstructive Sleep Apnoea (OSA) is a common disorder of breathing during sleep. In this condition there are frequent but brief episodes of obstruction to the upper airway. This causes episodes where breathing slows or stops, followed by a fall in the body’s oxygen level, rise in blood pressure, and a slight wakening of the person. This can happen hundreds of times a night. The most common symptom from OSA is tiredness during the day due to poor quality sleep, but many people have no symptoms. Patients with OSA are treated with continuous positive airway pressure (CPAP) at night to prevent airway obstruction, which stops the change to oxygen levels, blood pressure, and sleep disturbance. OSA is more common in people with type 2 diabetes compared to non-diabetics, and those people with type 2 diabetes and OSA are more likely to have worse diabetic eye disease. It is currently not clear why this is. In a recent small study where CPAP was used in these people in addition to standard treatment from their eye hospitals, there was an improvement in eye sight after six months treatment, if they had used the CPAP regularly. This larger study aims to establish whether giving CPAP treatment to adults with obstructive sleep apnoea, type 2 diabetes, and established diabetic retinopathy, really can improve their vision.

Who can participate?
Patients with type 2 diabetes and related retinopathy

What does the study involve?
Before being entered into the study, consenting patients are screened for obstructive sleep apnoea by having a simple overnight sleep study done at their home. Patients suitable for the study then meet the study team. The study lasts for 12 months. During this time patients are seen 4 or 5 times. At each visit visual acuity (clarity or clearness of vision) is measured, retinal images are taken, quality of life questionnaires are completed, and blood tests are performed. Each visit is likely to take about an hour. After the initial visit, patients are randomly allocated into one of two groups. Group A are provided with CPAP therapy for a year in addition to the existing medical treatment. Group B receive no CPAP therapy and no change to the current medical treatment.

What are the possible benefits and risks of participating?
This study is being performed to investigate whether CPAP treatment in this setting is beneficial or not. Currently the answer to this is not known. Worldwide, thousands of people use CPAP for the treatment of OSA. It is a very well tolerated treatment without any serious side effects. Minor problems with this include nasal congestion, or discomfort from a poorly fitted mask.

Where is the study run from?
The study is being co-ordinated from the Newcastle upon Tyne Hospitals NHS Foundation Trust, but involves patients being seen in the Eye Hospital they are already known to.

When is study starting and how long is it expected to run for?
August 2012 to January 2017

Who is funding the study?
‘The ResMed Foundation’ (USA)

Who are the main contacts?
1. Dr Benjamin Prudon
Ben.prudon@nuth.nhs.uk
2. Dr Sophie West, Respiratory Consultant
Sophie.west@nuth.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sophie West

ORCID ID

Contact details

Newcastle Regional Sleep Service
Freeman Hospital
Newcastle upon Tyne
NE7 7DN
United Kingdom
+44 (0)191 244 7468
sophie.west@nuth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0.6

Study information

Scientific title

A randomised controlled trial of continuous positive airway pressure (CPAP) in patients with impaired vision due to diabetic Retinopathy and concurrent Obstructive Sleep Apnoea (OSA): ROSA trial

Acronym

ROSA

Study hypothesis

Diabetic individuals are significantly more likely to have obstructive sleep apnoea (OSA) compared to the background population, independent of their body mass index (BMI). Individuals with diabetes and OSA are also more likely to develop severe diabetic retinopathy. Untreated OSA is associated with frequent surges in blood pressure and dips in arterial oxygenation during sleep, which may be a significant uncontrolled factor involved in the progression of diabetic retinopathy. A small initial trial treating these patients with continuous positive airway pressure (CPAP) improved vision at 6 months. This randomised controlled trial (RCT) aims to investigate whether CPAP treatment in individuals with diabetic retinopathy and concurrent OSA does improve vision.

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Obstructive sleep apnoea and visual impairment due to diabetic retinopathy

Intervention

Patients randomised to receive continuous positive airway pressure (CPAP) treatment with standard ophthalmology care, or only standard ophthalmology care.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Best corrected visual acuity (BCVA) with the study eye at 12 months (LogMAR with refraction, 4 metre Early Treatment of Diabetic Retinopathy Study protocol [ETDRS])

Secondary outcome measures

1. Best corrected visual acuity (BCVA) with the study eye at 6 months (LogMAR with refraction, 4 metre ETDRS)
2. Optical coherence tomography (OCT) central macular thickness in the study eye at 12 months (central 1mm average of radial line scans)
3. Number of ocular interventions for the study eye over 12 months (such as laser photocoagulation or intraocular injections of anti-VEGF)
4. Progression of diabetic retinopathy in the study eye at 12 months (assessed through retinal photography)
5. CPAP usage (hours/night)

Overall trial start date

01/08/2012

Overall trial end date

31/01/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 08/02/2013:
1. Type II diabetes mellitus (diagnosed on standard criteria), on diet, exercise and/or drug/insulin treatment
2. Visual impairment in at least one eye due to diabetes
3. Best corrected visual acuity (BCVA) ≥ 39 and ≤ 78 letters in at least one eye (using Early Treatment Diabetic Retinopathy Study protocol (ETDRS) at a testing distance of 4 meters)
4. Residual vision in one or both eyes
5. Macular oedema in the visually impaired eye(s)
6. 4% ODI ≥ 20/hour on the screening study
7. Aged ≥30 to ≤85
8. Patient willing to have nasal CPAP treatment

Previous inclusion criteria until 08/02/2013:
1. Type II diabetes mellitus (diagnosed on standard criteria), on diet, exercise and/or drug/insulin treatment
2. Visual impairment in at least one eye due to diabetes
3. Best corrected visual acuity (BCVA) ≥ 39 and ≤ 78 letters in at least one eye (using Early Treatment Diabetic Retinopathy Study protocol (ETDRS) at a testing distance of 4 meters)
4. Residual vision in one or both eyes
5. Macular oedema in the visually impaired eye(s)
6. Diagnosis of macular oedema within last 5 years
7. 4% ODI ≥ 20/hour on the screening study
8. Aged ≥30 to ≤85
9. Patient willing to have nasal CPAP treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150 patients will be randomised into the trial, to achieve this it is estimated 600 patients will need to be screened

Participant exclusion criteria

1. Type 1 diabetes mellitus
2. Previous treatment with CPAP or non-invasive ventilation for OSA
3. Any severe complication of OSA syndrome requiring CPAP
4. Substantial problems with sleepiness, for example while driving
5. Respiratory failure (awake resting arterial oxygen saturation <93%)
6. Cataract affecting vision such that fundal assessment at baseline on slit lamp/photography is inadequate
7. Previous ophthalmological intervention rendering visual improvement in at least one eye very unlikely, as assessed by recruiting ophthalmologist
8. Mental or physical disability precluding informed consent or compliance with the protocol for the duration of the study

Recruitment start date

23/10/2012

Recruitment end date

31/01/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Freeman Hospital
Newcastle upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

Royal Victoria Infirmary
Dept of Ophthalmology
Newcastle
NE1 4LP

Trial participating centre

Sunderland Eye Infirmary
SR2 9HP

Trial participating centre

St James’s University Hospital
Dept of Ophthalmology
Leeds
LS9 7TF

Trial participating centre

Bradford Royal Infirmary
Dept of Ophthalmology
BD9 6RJ

Trial participating centre

Bristol Eye Hospital
Retinal Research Unit
BS1 2LX

Trial participating centre

Royal Derby Hospital
Dept of Ophthalmology
DE22 3DT

Trial participating centre

Heartlands Hospital
Medical Innovation Development Research Unit
Birmingham
B9 5SS

Trial participating centre

The Royal Bournemouth Hospital
Dept of Ophthalmology
BH7 7DW

Trial participating centre

Blackpool Victoria Hospital
Clinical Research Centre
FY3 8NR

Trial participating centre

University Hospital of North Durham & Darlington Memorial Hospital
Dept of Ophthalmology
DL3 6HX

Trial participating centre

The James Cook University Hospital, Middlesbrough
Dept of Ophthalmology
TS4 3BW

Trial participating centre

Manchester Royal Eye Hospital
M13 9WL

Trial participating centre

Hospital of St Cross Rugby & University Hospital Coventry
Dept of Ophthalmology
CV22 5PX

Trial participating centre

University Hospital Southampton
Dept of Ophthalmology
SO16 6YD

Trial participating centre

Royal Shrewsbury Hospital
Dept of Ophthalmology
SY3 8XQ

Trial participating centre

Pinderfields Hospital
Dept of Ophthalmology
Wakefield
WF1 4DG

Trial participating centre

Musgrove Park Hospital
Respiratory & Ophthalmology
Taunton
TA1 5DA

Trial participating centre

University Hospital of North Staffordshire
Respiratory & Ophthalmology
Stoke-on-Trent
ST4 6QG

Trial participating centre

Derriford Hospital (Royal Eye Infirmary)
Respiratory & Ophthalmology
Plymouth
PL6 8DH

Trial participating centre

Belfast Health and Social Care Trust
Respiratory & Ophthalmology
BT12 6BA

Trial participating centre

Huddersfield Royal Infirmary
Dept of Ophthalmology
HD3 3EA

Trial participating centre

King's College Hospital
Respiratory & Ophthalmology
London
SE5 9RS

Trial participating centre

Royal Hallamshire Hospital
Respiratory & Ophthalmology
Sheffield
S10 2JF

Sponsor information

Organisation

Newcastle upon Tyne NHS Foundation Trust (UK)

Sponsor details

Joint Research Office
Level 6
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 282 4523
jillian.peacock@nuth.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

ResMed Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Submit data to American Thoracic Society by November 2017 for dissemination at ATS conference May 2018. Planned publication in a high-impact peer reviewed journal. Intention to publish date - early 2018.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

31/01/2018

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/10/2017: The following changes were made to the trial record: 1. The recruitment dates were added. 2. The overall trial end date was changed from 01/08/2015 to 31/01/2017. 3. Trial participating centres added. 4. Publication and dissemination plan and IPD sharing statement added.