Effect of electronic nicotine delivery systems for smoking cessation on sleep quality: secondary analysis of a randomized controlled trial.

Study Objectives E-cigarettes can help smokers quit, but how e-cigarettes used for tobacco smoking cessation impact sleep is still unclear. The primary objective was to evaluate the effect of e-cigarettes for smoking abstinence on sleep quality. Secondary objectives included subscales of sleep quality.Methods We conducted a secondary analysis of the Efficacy, Safety, and Toxicology of electronic nicotine delivery systems for smoking cessation (ESTxENDS) randomized controlled trial, which included adult smokers in Switzerland (5 sites, 7.2018-6.2021). The intervention group received free e-cigarettes and e-liquids over 6 months plus standard-of-care smoking-cessation counseling (SOC); the control group received SOC alone. The primary outcome was overall self-reported sleep quality at 6 months, measured by the Pittsburgh Sleep Quality Index (PSQI). We considered a minimal clinically important difference (MCID) of 2.5-5. Secondary outcomes included PSQI subscales. We used adjusted linear regressions with inverse probability of attrition weights (IPAW).Results ESTxENDS included 1246 participants. Of these, 831 participants completed the PSQI at follow-up. For the primary outcome, there was no significant difference in PSQI score between groups (b=-0.20, p=.256, adjusted analyses with IPAW). For PSQI subscales, only sleep efficiency was significantly better in the intervention group (b=1.87, p=.018), below MCID.Conclusion E-cigarettes added to SOC for tobacco smoking abstinence did not significantly alter participant's self-reported sleep quality compared to SOC alone. Clinicians can inform patients willing to quit smoking with e-cigarettes that their use is not likely to disrupt their perceived sleep quality on average.