Abstract
Objective: Previous research indicates that pain treatment may improve sleep among nursing home patients. We aimed to investigate the long-term effect of pain treatment on 24-h sleep patterns in patients with comorbid depression and dementia.Design: A 13-week, multicenter, parallel-group, double-blind, placebo-controlled randomized clinical trial conducted between August 2014 and September 2016.Setting: Long-term patients from 47 nursing homes in Norway.Participants: We included 106 patients with comorbid dementia and depression according to the Mini Mental Status Examination (MMSE) and the Cornell Scale for Depression in Dementia (CSDD).Intervention: Patients who were not using analgesics were randomized to receive either paracetamol (3 g/day) or placebo tablets. Those who already received pain treatment were randomized to buprenorphine transdermal system (maximum 10 μg/h/7 days) or placebo transdermal patches.Measurements: Sleep was assessed continuously for 7 days by actigraphy, at baseline and in week 13. Total sleep time (TST), sleep efficiency (SE), sleep onset latency (SOL), wake after sleep onset (WASO), early morning awakening (EMA), and number of wake bouts (NoW) were evaluated. In addition, daytime total sleep time (DTS) was estimated. Pain was assessed with Mobilization-Observation-Behavior-Intensity-Dementia-2 Pain Scale (MOBID-2).Results: The linear mixed model analyses for TST, SE, SOL, WASO, EMA, NoW and DTS showed no statistically significant differences between patients who received active pain treatment and those who received placebo. Post hoc subgroup analyses showed that there were no statistically significant differences between active treatment and placebo from baseline to week 13 in patients who were in pain (MOBID-2 ≥ 3) at baseline, or in patients who had poor sleep (defined as SE < 85%) at baseline. Patients who received active buprenorphine showed an increase in TST and SE compared to those who received active paracetamol.Conclusion: The main analyses showed that long-term pain treatment did not improve sleep as measured with actigraphy. Compared to paracetamol, TST and SE increased among patients who received buprenorphine. This could indicate that some patients had beneficial effects from the most potent pain treatment. However, based on the present findings, long-term pain treatment is not recommended as a strategy to improve sleep. Clinical Trial https://clinicaltrials.gov/ct2/show/NCT02267057.
Highlights
46.8 million people worldwide suffer from dementia – a number estimated to reach 131.5 million by 2050 (Prince et al, 2016)
In a recently published randomized controlled trial, based on the same dataset and respondents as the present work, we found that compared to placebo, pain treatment improved sleep after 1 week of treatment (Blytt et al, 2017a)
In additional post hoc subgroup analyses, we further aimed to investigate if improvement of sleep from pain treatment was larger in patients who were in pain at baseline, defined as Mobilization-Observation-Behavior-Intensity-Dementia-2 Pain Scale (MOBID-2) score ≥ 3, than in those who were not
Summary
46.8 million people worldwide suffer from dementia – a number estimated to reach 131.5 million by 2050 (Prince et al, 2016). In nursing homes (NH), 50–80% of patients have dementia (Helvik et al, 2015; Blytt et al, 2017b), a neurodegenerative condition that results in the decline of physical and cognitive functions (Cricco et al, 2001). Sleep disturbances are common among NH patients with dementia, with prevalence ranging from 24.5% (Moran et al, 2005) to 60% (Neikrug and Ancoli-Israel, 2010; Ownby et al, 2014; PeterDerex et al, 2015). Dementia may induce pathophysiological changes in the brain, which can interfere with the maintenance of normal sleep (Moran et al, 2005; Neikrug and AncoliIsrael, 2010). Previous studies have reported that people with dementia have more disturbed sleep than do patients without dementia (Pat-Horenczyk et al, 1998). Sleep disturbances contribute to impaired daytime functioning (Cricco et al, 2001)
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