An exploratory analysis of actigraphy and sleep diaries in a methamphetamine withdrawal clinical trial

Sleep disturbance is a common during methamphetamine (MA) use and withdrawal. To date only questionnaire-based sleep assessments have been used to assess sleep disturbance in this population. Actigraphy is a well-established, non-invasive measure of sleep-wake with comparable accuracy to gold-standard polysomnographic sleep studies. This is the first study to investigate the feasibility and utility of using actigraphy and sleep diaries to investigate sleep during MA withdrawal.

We conducted an open-label single-arm clinical trial to investigate the safety and feasibility of 5-day tapering-dose lisdexamfetamine for the treatment of MA withdrawal. Participants were inpatients for 7 days and continuously wore an actigraph (Philips Actiwatch 2) and completed a modified Consensus Sleep Diary each morning. Participants were interviewed between days 3-5.

10 participants (mean age 37 years, 90% male) were enrolled in the pilot study. Participants interviewed (n=8) reported that the actigraph was not difficult or distracting to wear or completion of daily sleep diary onerous. No participants removed the device prematurely. Actigraphic average sleep duration was 646 mins, sleep onset latency (SOL) 20 min and wake after sleep onset (WASO) 78 min. Sleep diaries underreported sleep compared with actigraphy (sleep duration was 141 minutes (p=0.005) and WASO 45 min (p<0.001) less). Mean sleep efficiency was 83.9%, however participants rated their overall sleep quality at 4.7 on a nine-point scale.

Continuous actigraphy is feasible to measure sleep-wake cycles in people withdrawing from MA, with high accuracy and low participant burden, and could be trialled in long-term outpatient monitoring. We found important differences in self-reported and actigraphic sleep, which need to be explored in more detail. Accurate sleep measurement is essential to better understand stimulant use and withdrawal, and has the potential to be used as an efficacy outcome in future trials and clinical practice.