Prevalence and treatment of sleep-disordered breathing in Down's syndrome

ISRCTN ISRCTN55685305
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
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

Department of Sleep Medicine
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Phone +44 (0)131 242 3882
Email rlriha@hotmail.com

Study information

Study designRepeated measures parallel-arm controlled intention to treat study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleControlled prospective trial of the effectiveness of continuous positive airway pressure therapy in adults with Down's syndrome
Study objectivesContinuous 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) studiedSleep disordered breathing, obstructive sleep apnoea, Down's syndrome
InterventionAll 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 typeOther
Primary outcome measure1. 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 measures1. 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 date01/02/2011
Completion date31/12/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants68
Total final enrolment28
Key inclusion criteriaFor 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 criteria1. 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 enrolment01/02/2011
Date of final enrolment31/12/2014

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study 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

University of Edinburgh and NHS Lothian (UK) - Joint Sponsorship
University/education

c/o Gemma Watson
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom

Phone +44 (0)131 242 9461
Email gemma.watson@ed.ac.uk
Website http://www.ed.ac.uk/home
ROR logo "ROR" https://ror.org/03q82t418

Funders

Funder type

Government

Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZH/4/549)

No information available

Fondation Jerome Lejeune (France) (ref: R41361-195RSP)

No information available

Added 08/10/2013:

No information available

Baily Thomas Charitable Trust (ref: TRUST/RNA/AC/TM/2634-5178)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
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.