REFRESHED V4.0
Research type
Research Study
Full title
REFRESHED - REal world clinical outcomes FRom trEatment and evaluation of oSas in cHildrEn with Down syndrome, Version 4.0
IRAS ID
324943
Contact name
Florian Gahleitner
Contact email
Sponsor organisation
National Children's Research Centre
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Obstructive Sleep Apnoea Syndrome (OSAS) affects almost half of children with Down Syndrome. It has significant adverse consequences for developmental and cardiac outcomes. It is treated with positive airway pressure (PAP) which holds the airway open, preventing collapse during sleep. While PAP is a very effective treatment, only half of children are adherent to therapy.
This study will collect questionnaire data regarding quality of life, sleep behaviours and adherence alongside information from sleep studies and PAP device downloads obtained as part of standard care. An additional advanced study group will be invited to take part in semi-structured qualitative interviews examining expectations, experiences and barriers experienced by families in the treatment of OSAS with PAP. This study will be divided into 2 parts. Phase 1 will take place over an initial 12-month period and will verify the robustness and relevance of the questionnaires used. Phase 2 will take place over the subsequent 4 years and aims to achieve recruitment of 150 participants.
Our project has three major aims. Firstly, we aim to establish the impact of OSAS treatment on behavioural and quality of life outcomes. Secondly, we aim to describe the barriers to tolerating treatment to inform the development of practical innovative solutions (e.g. story books, parent information leaflets, etc) that can be delivered by caregivers and healthcare providers. Thirdly, we aim to verify the validity of outcome measures used and establish their relevance to children with Down Syndrome to inform the conduct of future research trials.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
23/EM/0131
Date of REC Opinion
27 Jun 2023
REC opinion
Further Information Favourable Opinion