The POPPY Sleep Sub-Study
Research type
Research Study
Full title
The POPPY Sleep Sub-Study
IRAS ID
216242
Contact name
Alan Winston
Contact email
Sponsor organisation
Imperial College
Clinicaltrials.gov Identifier
NCT01737047, POPPY main study ClinicalTrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Very little is known about the effects, if any, being HIV positive and being on anti-HIV medication may have on sleeping and sleep patterns. The aims of this study are to see if sleep is affected by being HIV positive, and if any changes to sleep then affect other functions in the body such as brain function.
It is a sub-study of the POPPY (Pharmacokinetic and Clinical Observations in People Over Fifty) study and the aim is for 500 main study participants to join this sub-study. It is an observational study (does not require participants to take any specific medication) taking place at 7 hospitals in the UK and Ireland. It is anticipated it will take around 2 years to complete the visits on 500 participants. This sub-study is being funded by the National Institutes of Health in the USA.
The research involves a study visit at the clinic which is expected to take up to 2 hours. At this visit participants will undergo brain function (cognitive) tests, complete a study questionnaire, give a brief medical history regarding their sleep and have some clinical measurements taken. Participants will then be given 2 devices and a sleep diary to complete over 7 days. The first device is an Actigraph which records physical activity and sleep/wake patterns and will be worn for 7 consecutive days and nights. The second device, which will be worn for only one of those nights, is a pulse oximeter which records the levels of oxygen in the blood. The participants will return the devices and diaries to clinic at the end of the 7 days and have a fasting blood sample taken.
There are no specific advantages to taking part but information gained may be of benefit in the treatment of HIV positive patients in the future.REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/2175
Date of REC Opinion
20 Dec 2016
REC opinion
Favourable Opinion