Contact information
Type
Scientific
Primary contact
Dr Renata Riha
ORCID ID
Contact details
Department of Sleep Medicine
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
+44 (0)131 242 3882
rlriha@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Controlled prospective trial of the effectiveness of continuous positive airway pressure therapy in adults with Down's syndrome
Acronym
Study hypothesis
Continuous positive airway pressure (CPAP) use in Down's syndrome (DS) adults with obstructive sleep apnoea/hypopnoea syndrome (OSAHS)/sleep-disordered breathing (SDB) improves sleepiness and quality of life more effectively than lifestyle measures alone.
Ethics approval
Scotland A Research Ethics Committee, 28/02/2011 and substantial amendment on 17/05/2011, ref: 11/MRE00/3
Study design
Repeated measures parallel-arm controlled intention to treat study
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 below to request a patient information sheet
Condition
Sleep disordered breathing, obstructive sleep apnoea, Down's syndrome
Intervention
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 written lifestyle advice on diet, exercise, sleep hygiene and sleeping position. Participants allocated to the CPAP Group will receive CPAP at the optimal pressure to treat their symptoms, along with written lifestyle advice as per the Lifestyle Group. Participants in both groups will be followed up at 1 week & at 1 month after randomisation. After 1 month, the Lifestyle Group will be offered CPAP, with additional follow ups at 1 week and 1 month after commencing CPAP. Both groups will then be followed at 3 months and 6 months after randomisation. At 6 months, participation in the study is complete, and all participants will be encouraged to remain on CPAP.
Participants in both limbs will have anthropometric measures, cognitive function tests, health questionnaires, carer questionnaires and documentation of healthcare contact at baseline (randomisation), 1 month, 3 months & 6 months. All participants will complete and return a monthly diary recording health care contact, caffeine intake, medication, health questionnaires and a carer questionnaire.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 outcome measures
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
Overall trial start date
01/02/2011
Overall trial end date
31/12/2014
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
68
Participant 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
Recruitment start date
01/02/2011
Recruitment end date
31/12/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Sleep Medicine
The Royal Infirmary of Edinburgh
51 Little France Crescent
Old Dalkeith Road
Edinburgh
EH16 4SA
United Kingdom
Sponsor information
Organisation
University of Edinburgh and NHS Lothian (UK) - Joint Sponsorship
Sponsor details
c/o Gemma Watson
The Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 9461
gemma.watson@ed.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZH/4/549)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Fondation Jerome Lejeune (France) (ref: R41361-195RSP)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Added 08/10/2013:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Baily Thomas Charitable Trust (ref: TRUST/RNA/AC/TM/2634-5178)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary