Prevalence and treatment of sleep-disordered breathing in Down's syndrome
ISRCTN | ISRCTN55685305 |
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DOI | https://doi.org/10.1186/ISRCTN55685305 |
Secondary identifying numbers | 1 |
- Submission date
- 20/12/2010
- Registration date
- 03/02/2011
- Last edited
- 27/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Department of Sleep Medicine
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Phone | +44 (0)131 242 3882 |
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rlriha@hotmail.com |
Study information
Study design | Repeated measures parallel-arm controlled intention to treat study |
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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 | Controlled prospective trial of the effectiveness of continuous positive airway pressure therapy in adults with Down's syndrome |
Study objectives | 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(s) | Scotland A Research Ethics Committee, 28/02/2011 and substantial amendment on 17/05/2011, ref: 11/MRE00/3 |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/02/2011 |
Completion date | 31/12/2014 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 68 |
Total final enrolment | 28 |
Key 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) |
Key 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 |
Date of first enrolment | 01/02/2011 |
Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
51 Little France Crescent
Old Dalkeith Road
Edinburgh
EH16 4SA
United Kingdom
Sponsor information
University/education
c/o Gemma Watson
The Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
Phone | +44 (0)131 242 9461 |
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gemma.watson@ed.ac.uk | |
Website | http://www.ed.ac.uk/home |
https://ror.org/03q82t418 |
Funders
Funder type
Government
No information available
No information available
No information available
No information available
Results and Publications
Intention to publish date | |
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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 | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Other publications | Validation of pictorial Epworth sleepiness scale in adults with Down syndrome | 01/02/2020 | 18/12/2020 | Yes | No |
Results article | 12/11/2020 | 27/10/2022 | Yes | No |
Editorial Notes
27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
18/12/2020: Publication reference added.
12/01/2017: No publications found in PubMed. Verifying study status with principal investigator.
08/10/2013: Anticipated end date was changed from 01/02/2013 to 31/12/2014.