Sleep apnoea Nervous System Diseases Sleep disorders
Conditions
Interventions
Treatment (Continuous positive airway pressure) limb
Obstructive sleep apnoea will be diagnosed from a diagnostic overnight polysomnographic sleep study. After trial entry, subjects assigned to CPAP
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 07/04/2010: 1. Aged greater than 65 years, either sex 2. A clinical diagnosis of OSAHS: more than/equal to 4% oxygen desaturation index greater than 7.5 events/hour and an Epworth sleepiness scale more than/equal to 9 3. Ability to give written informed consent Previous inclusion criteria at time of registration: 1. Both males and females, aged greater than 65 years 2. Apnoea hypopnoea index greater than or equal to 15 events/hour of sleep on multi-channel sleep study, and at least two symptoms of excessive daytime sleepiness or Epworth sleepiness scale greater than or equal to 11 3. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Previous exposure to nasal CPAP therapy 2. Arterial oxygen saturation less than 93% 3. Forced expiratory volume in one second (FEV1) less than 65% predicted 4. Substantial problems with sleepiness driving (in those who are still driving); currently using Heavy Goods Vehicle (HGV) or Public Service Vehicle (PSV) driving licence (where applicable) 5. Shift work 6. Inability to give informed consent or comply with the protocol 7. Irreversible visual impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following will be measured throughout the whole of the 12-month trial period: 1. Subjective sleepiness: average weekly Epworth Sleepiness Scale (ESS) 2. Health economic analysis: measured from health care utilisation and cost utility analysis using the EQ-5D | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 07/04/2010: The following will be measured throughout the whole of the 12-month trial period: 1. Objective sleepiness: Oxford Sleep Resistance Test (OSLER) maintenance of wakefulness test (x 2 morning tests) 2. Self reported health status (quality of life and mood): 36-item Short Form questionnaire (SF-36), and Sleep Apnoea Quality of Life Index (SAQLI; a disease specific sleep apnoea questionnaire which includes CPAP side effects), Hospital Anxiety and Depression Scale (HADS) 3. Functional index of activities of daily living: Townsend Disability Scale (TDS) 4. Frequency of nocturia: Self reported using the patient [monthly] diary 5. Mobility: Timed to up and go test 6. Accidents: Including self-reported road accidents and domestic accidents 7. Cognitive function: Mini-mental state, Trail making B time, the Digit Symbol Substitution test, simple and four-choice reaction time 8. Cardiovascular Risk Index: Change in combined stroke and myocardial infarction risk measured by the Framingham vascular risk index, which includes office blood pressure, cholesterol, smoking status, hyperglycaemia 9. Adverse cardiovascular events: Myocardial infarction, stroke, transient ischemic attack, new angina, new atrial fibrillation, new peripheral vascular disease Previous secondary outcome measures at time of registration: The following will be measured throughout the whole of the 12-month trial period: 1. Objective sleepiness: measured using the maintenance of wakefulness test of the Oxford sleep resistance test (OSLER) 2. Self-reported health status (quality of life): the 36-item Short Form health survey (SF-36), CASP-19, the Short Sleep Apnea Quality of Life Index (SAQLI) questionnaire (which includes CPAP side effects) 3. Accidents, including road accidents 4. Change in combined stroke and myocardial infarction risk: measured by the Framingham Index 5. Individual components of the Framingham vascular risk index; blood pressure, choles | — |
Countries
United Kingdom
Outcome results
None listed