Condition category
Nervous System Diseases
Date applied
20/12/2010
Date assigned
03/02/2011
Last edited
28/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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.

On 08/10/2013, the anticipated end date was changed from 01/02/2013 to 31/12/2014.

Ethics approval

Scotland A Research Ethics Committee on 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
Edinburgh
EH16 4SA
United Kingdom

Sponsor information

Organisation

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

Sponsor details

c/o Gemma Watson
The Queen’s 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

http://www.ed.ac.uk/home

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

Publication citations

Additional files

Editorial Notes