Continuous positive airway pressure (CPAP) in patients with impaired vision due to diabetic Retinopathy and concurrent Obstructive Sleep Apnoea (OSA): ROSA trial
| ISRCTN | ISRCTN95411896 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95411896 |
| Secondary identifying numbers | 0.6 |
- Submission date
- 17/05/2012
- Registration date
- 28/05/2012
- Last edited
- 01/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
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 bodys 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
Contact information
Scientific
Newcastle Regional Sleep Service
Freeman Hospital
Newcastle upon Tyne
NE7 7DN
United Kingdom
| Phone | +44 (0)191 244 7468 |
|---|---|
| sophie.west@nuth.nhs.uk |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study 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(s) | Not provided at time of registration |
| 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 |
| Primary outcome measure | 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 study start date | 01/08/2012 |
| Overall study end date | 31/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | 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 |
| Total final enrolment | 131 |
| 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 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
- England
- Northern Ireland
- United Kingdom
Study participating centres
NE7 7DN
United Kingdom
Newcastle
NE1 4LP
United Kingdom
United Kingdom
Leeds
LS9 7TF
United Kingdom
BD9 6RJ
United Kingdom
BS1 2LX
United Kingdom
DE22 3DT
United Kingdom
Birmingham
B9 5SS
United Kingdom
BH7 7DW
United Kingdom
FY3 8NR
United Kingdom
DL3 6HX
United Kingdom
TS4 3BW
United Kingdom
United Kingdom
CV22 5PX
United Kingdom
SO16 6YD
United Kingdom
SY3 8XQ
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Taunton
TA1 5DA
United Kingdom
Stoke-on-Trent
ST4 6QG
United Kingdom
Plymouth
PL6 8DH
United Kingdom
BT12 6BA
United Kingdom
HD3 3EA
United Kingdom
London
SE5 9RS
United Kingdom
Sheffield
S10 2JF
United Kingdom
Sponsor information
Hospital/treatment centre
Joint Research Office
Level 6, Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
| Phone | +44 (0)191 282 4523 |
|---|---|
| jillian.peacock@nuth.nhs.uk | |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The ResMed Foundation, Resmed Foundation Ltd, Resmed Foundation Limited
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/01/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 25/10/2018 | 01/10/2020 | Yes | No |
Editorial Notes
01/10/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
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.
