Prevention of morbidity in sickle cell disease: phase II (POMS 2b)
Research type
Research Study
Full title
Prevention of morbidity in sickle cell disease Phase II (Improvement of Pain and Quality of Life in Patient with Sickle Cell Disease with Auto-adjusting Continuous Positive Airways Pressure: Phase II) (POMS 2b)
IRAS ID
179171
Contact name
Fenella Kirkham
Contact email
Sponsor organisation
University hospital Southampton
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Sickle cell disease (SCD) is a genetic blood condition causing long term health problems including pain and brain problems which affect quality of life. These may be made worse if patients have low night-time oxygen levels.
The aim of this trial is to compare standard treatment with a machine to prevent low night-time oxygen levels in patients with sickle cell disease (SCD). The machine, called auto-adjusting continuous positive airways pressure (APAP), overcomes obstruction to the airway and we will see if this provides physical benefits. We think this treatment would be useful in patients with SCD as preventing low night-time oxygen levels might help to decrease pain and improve concentration. It may also reduce hospital admissions.
This trial, funded by National Institute for Health Research, will involve 60 SCD patients (30 children and 30 adults) recruited from haematology clinics at Guy’s & St Thomas and King’s College Hospitals. Patients will be eligible if they are over 8 years old with severe SCD, give informed consent, and have overnight oximetry showing minimum overnight oxygen saturation of <94%.
After consenting, the patients will have screening tests including overnight oximetry. Patients with abnormal overnight oximetry will be randomised to standard care with no overnight breathing support or to APAP most nights for a 6 month period. Patients will be asked to collect data on pain symptoms via a mini i-Pad at the start and finish. They will have blood tests, tests of brain and heart health. If in the intervention arm, the APAP machine will be set up at the patient’s home.
The trial will recruit from June 2015 and patients will be in the study for 6 months with 2 home and 4 hospital visits. The trial is registered with International Standard Randomised Controlled Trial (ISRCT). For further information please contact Dr Fenella Kirkham: Fenella.Kirkham@ucl.ac.uk
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
15/YH/0213
Date of REC Opinion
16 Jun 2015
REC opinion
Further Information Favourable Opinion