Effect of continuous positive airway pressure (CPAP) therapy on arterial stiffness in patients with obstructive sleep apnoea/hypopnoea syndrome (OSAHS)
| ISRCTN | ISRCTN48783995 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48783995 |
| Secondary identifying numbers | PG/06/092/21267 |
- Submission date
- 07/07/2010
- Registration date
- 27/07/2010
- Last edited
- 02/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Renata Riha
Scientific
Scientific
Department of Sleep Medicine
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Study information
| Study design | Randomised double blind placebo-controlled crossover 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 below to request a patient information sheet |
| Scientific title | Aortic distensibility in obstructive sleep apnoea/hypopnoea syndrome (OSAHS) using cardiovascular magnetic resonance imaging and and pulse wave analysis: effect of continuous positive airway pressure (CPAP) therapy |
| Study objectives | Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) affects 1 - 4 % of the middle-aged population causing excessive daytime sleepiness. A greater proportion of the population will exhibit sleep disordered breathing, but will not complain of excessive daytime sleepiness. OSAHS is associated with a significantly increased risk of cardiovascular disease and hypertension. The causes of this are likely to be multifactorial and may include repeated oxygen desaturations or factors associated with the excessive daytime sleepiness. Postulated mechanisms for this increased risk include increased arterial stiffness and endothelial dysfunction, which can be measured non-invasively using applanation tonometry (pulse wave velocity and analysis) and cardiovascular magnetic resonance imaging (MRI). Continuous positive airway pressure (CPAP) therapy is an established treatment for OSAHS and is useful in reducing symptoms, it has also been shown to reduce blood pressure in sleepy patients with OSAHS. This study aims to measure the effect that CPAP therapy has upon arterial stiffness and endothelial function in patients with OSAHS. By studying patients with varying degrees of OSAHS, both in terms of nocturnal oxygen desaturation and levels of daytime sleepiness, but without known cardiovascular disease we hope to further examine the factors that are important in determining arterial stiffness and endothelial dysfunction in these patients. |
| Ethics approval(s) | Lothian Local Research Ethics Committee 02, 24/01/2007, ref: 06/S1102/54 |
| Health condition(s) or problem(s) studied | Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) |
| Intervention | Patients meeting the inclusion criteria will be recruited from the Department of Sleep Medicine. This is a randomised controlled crossover trial with 12 weeks in each limb. The active treatment limb consists of CPAP set to provide optimal pressures for treatment and the placebo limb utilises sham CPAP set to provide a sub-optimal pressure. At baseline and after each limb of the study patients will undergo the following measurements: 1. Pulse wave velocity (PWV) and pulse wave analysis (PWA) - before and after administration of GTN and salbutamol 2. Cardiovascular MRI of aorta 3. Blood pressure recording 4. Epworth Sleepiness Score Control subjects will undergo the above investigations once. Patients spent approximately 12 weeks in each limb; total duration of treatment is therefore approximately 24 weeks in total for intervention group. Control subjects were assessed once and there was no further follow up after this. |
| Intervention type | Other |
| Primary outcome measure | Arterial stiffness as measured by PWV/PWA and aortic distensibility as measured by cardiovascular MRI, at timepoints 0, 12 and 24 weeks |
| Secondary outcome measures | Measured at timepoints 0, 12 and 24 weeks: 1. Endothelial function as measured by pulse wave analysis (before and after administration of GTN and salbutamol) 2. Blood pressure changes |
| Overall study start date | 01/02/2007 |
| Completion date | 04/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 80 (including 60 patients with varying severity of disease and 20 controls) |
| Key inclusion criteria | Both: 1. Males and females aged 18 - 65 years Patients: 2. Apnoea Hypopnoea Index (AHI) greater than or equal to 15 at polysomnography 3. CPAP naive 4. Ability to give written informed consent Control subjects: 5. AHI less than or equal to 10 at polysomnography 6. Epworth Sleepiness Score (ESS) less than 11 7. Ability to give written informed consent |
| Key exclusion criteria | 1. Inability to give written informed consent 2. Known cardiovascular disease or diabetes 3. History of respiratory failure 4. Medications affecting blood pressure 5. Reported sleepiness when driving or those who drive for a living 6. Claustrophobia precluding magnetic resonance imaging (MRI) scanning 7. Implanted/foreign bodies precluding MRI scanning |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 04/08/2009 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Department of Sleep Medicine
Edinburgh
EH16 4SA
United Kingdom
EH16 4SA
United Kingdom
Sponsor information
University of Edinburgh (UK)
University/education
University/education
Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Website | http://www.ed.ac.uk |
|---|---|
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
Charity
British Heart Foundation (BHF) (UK) (ref: PG/06/092/21267)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
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 | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2013 | Yes | No | |
| Results article | results | 01/12/2013 | Yes | No |
