Table 1 Outcome Measures
Outcome measure | Frequency | Tool used |
|---|---|---|
Sleep Quality and Quantity | Baseline, day 5, weeks 2, 4 & 8 | PSQI, Polar A370 sleep monitor (wrist actigraphy) and the consensus sleep diary |
Sleep onset latency | Baseline, day 5, weeks 2, 4 & 8 | Consensus sleep diary |
Sleep disturbance (waking during the night or waking too early) | Baseline, day 5, weeks 2, 4 & 8 | Wrist actigraphy, consensus sleep diary and the PROMIS sleep disturbance questionnaire |
Sleep inertia | Baseline, day 5, weeks 2, 4 & 8 | SIQ and wrist actigraphy |
Daytime sleepiness | Baseline, day 5, weeks 2, 4 & 8 | SIQ and consensus sleep diary |
Morning grogginess on waking | Baseline, day 5, weeks 2, 4 & 8 | SIQ and consensus sleep diary |
Daytime nap count and duration | Baseline, day 5, weeks 2, 4 & 8 | ESS and consensus sleep diary |
General quality of life | Baseline, day 5, weeks 2, 4 & 8 | SF-36 |
Pathology and Safety markers | Baseline and week 8 | Albumin, ALT, AST, GGT, total bilirubin, hsCRP, IL10, IL6, IL8 and TNFa |
Adverse events | Continuously | Spontaneously reported by the participant or noticed by a trial supervisor |