Skip to main content

Table 1 Outcome Measures

From: Palmitoylethanolamide for sleep disturbance. A double-blind, randomised, placebo-controlled interventional study

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
  1. PSQI Global Pittsburgh Sleep Quality Index, PROMIS Patient Reported Outcomes Measurement Information System, SIQ The Sleep Inertia Questionnaire, ESS Epworth Sleepiness Scale, SF-36 Rand 36-item Health Survey, ALT Alanintransaminase, AST Aspartate Transaminase, GGT Gamma-Glutamyl Transferase, hsCRP high sensitivity C-reactive Protein, IL interleukin, TNF Tumor Necrosis Factor