AMBIENT-BD
Research type
Research Study
Full title
Ambient and passive collection of sleep and circadian rhythm data in bipolar disorder to understand symptom trajectories and clinical outcomes
IRAS ID
351349
Contact name
Daniel J Smith
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
3 years, 5 months, 29 days
Research summary
This study is designed to investigate the association between sleep, circadian rhythm disturbances, and mood episodes in bipolar disorder.
Disturbed sleep and changes in normal activity are features of bipolar disorder and, when present, can increase the chances of a mood episode occurring. With a better understanding over longer time periods, we may be able to generate new ways to identify mood episodes early and possibly prevent them from occurring.
Our study therefore aims to recruit 180 individuals with bipolar disorder from across UK and to follow them up for a period of 18 months, which will be the largest and longest prospective study in this field.
The methods of data collection we will use aim to minimise the burden for participants as much as possible, and include:
Ambient and passive data collection:
o Axivity (a wrist-worn device) will assess activity levels. Participants will be asked to wear this four times over the study, for a period of nine weeks each time
o Somnofy (a bedside radar device) that will collect information about sleep and night-time movement throughout the 18 months
o Ecological Momentary Assessment (EMA): questionnaires repeated multiple times per day for one week assessing mood, anxiety and other outcomes using a smartphone app. A daily sleep diary will be taken at the same time.Screening, baseline and three follow-up appointments. Only the baseline appointment will be face-to-face and will involve a non-invasive eye examination to assess light sensitivity. Other visits will be remote and include assessments of lifestyle, current and previous mental health and medications, as well as wellbeing and day-to-day functioning.
Ultimately, this study will allow us to better understand the connection between sleep, circadian rhythm disturbances and mood episodes in bipolar disorder, and may help to identify opportunities to provide effective interventions to prevent mood relapses from occurring in the future.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
25/ES/0001
Date of REC Opinion
22 Jan 2025
REC opinion
Further Information Favourable Opinion