Sleep disordered breathing, obstructive sleep apnoea, Down's syndrome Respiratory Sleep disordered breathing
Conditions
Interventions
All participants with a diagnosis of sleep apnoea on home sleep study will be randomised to either the Lifestyle group or the CPAP Group. Participants allocated to the Lifestyle Group will receive wri
Sponsors
University of Edinburgh and NHS Lothian (UK) - Joint Sponsorship
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For the prevalence study: 1. Age greater than or equal to 16 years, either sex 2. A clinical diagnosis of Down's syndrome Additionally, for CPAP evaluation: 3. A clinical diagnosis of OSAHS (greater than or equal to 10 obstructive apnoeas hour on multichannel sleep study and symptoms of excessive daytime sleepiness or Epworth Sleepiness Scale [ESS] greater than or equal to 9) 4. Ability to give informed consent and comply with protocol (participant and/or relative/carer, as appropriate)
Exclusion criteria
Exclusion criteria: 1. Previous exposure to CPAP therapy 2. Arterial oxygen saturation less than 90% on room air 3. Participants with forced expiratory volume in one second (FEV1) less than 60% 4. Participants with chronic heart failure or recent myocardial infarction (heart attack) 5. Participants with known moderate or severe dementia 6. Participants with severe behavioural problems that would preclude sleep studies or CPAP treatment 7. Inability to give informed consent AND relative/carer unable or unwilling to give informed consent 8. Inability to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in Subjective Sleepiness: Epworth Sleepiness Scale (ESS) recorded at baseline, 1 week and monthly thereafter (averaged over 1, 3, and 6 months). 2. Change in health related quality of life: EQ-5D (measured at measured at baseline, 1, 3 and 6 months) valued using UK population tariffs. This will be used to estimate the cost per quality-adjusted life year (QALY) gained by providing CPAP in comparison to lifestyle measures. The analysis will incorporate health care utilisation, including hospital visits and GP visits during the trial (recorded by monthly diary) and 3 months prior to trial entry (obtained via GP letter and review of patient records). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective changes in emotional and behavioural function: Modified DBC-A - measured at baseline and monthly thereafter 2. Health status (quality of life): SF-12, SAQLI - baseline, 1, 3, 6 months 3. Cognitive function: All tests deleted, replaced with Arizona Cognitive Test Battery (ACTB) (Added 31/05/2011) 4. Adverse events: Side effects associated with CPAP usage, such as dry mouth - baseline and monthly thereafter, + 1 week after commencing treatment 5. Compliance with CPAP: Average hours of use per night from in-built machine timeclocks - baseline, 1, 3, 6 months 6. Carer burden: Modified CBI, GHQ-12, open-ended qualitative comments about the experience of caring - baseline and monthly thereafter Previous secondary outcome measures: 3. Cognitive function: Leiter-R, BPVSII, Raven Matrices, DSQIID - baseline, 1, 3, 6 months | — |
Countries
Scotland, United Kingdom
Outcome results
None listed