NCT03603353

The ESTxENDS Trial- Substudy on the Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Sleep Quality.

Substudy of Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (ESTxENDS Trial)- the Sleep Quality Substudy of ESTxENDS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,246 (actual)
• Sponsor: University of Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

--\> This is a substudy of the main ESTxENDS trial (NCT03589989). Sleep quality outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989. Cigarette smoking is the leading cause of preventable death in Switzerland and still more than a quarter of the Swiss population smokes cigarettes. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking. The majority of attempts to quit tobacco smoking do not end in success due to unpleasant withdrawal symptoms. One of such symptoms is disturbed sleep. Sleep disturbances are a problem for smokers who are trying to quit. Sleep disturbances results from difficulty falling asleep or frequent arousals after sleep onset, and have negative daytime consequences such as sleepiness and dysphoric mood. Studies indicate that awakenings during night affect the cardiovascular system by providing repetitive bursts of sympathetic nervous system activation, likely contributing to elevated levels of cardiovascular and cerebrovascular morbidity. ENDS with nicotine containing e-liquids may be effective in assisting with tobacco smoking cessation by reducing withdrawal-induced sleep disturbances. This study will therefore test the efficacy of ENDS for cigarette smoking cessation, the safety of ENDS on adverse events and the effect of ENDS on health-related outcomes and exposure to inhaled chemicals. For the main ESTxENDS trial (NCT03589989), cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. All participants will be followed over a 24-month period. Sleep quality will be assessed using the Pittsburgh sleep quality index- questionnaire at baseline and at 6, 12 and 24 months' follow-up.

Conditions

• Smoking Cessation
• Sleep

Interventions

Type	Name	Description
OTHER	ENDS (vaporizer/e-cig) and smoking cessation counseling	Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
OTHER	Smoking cessation counseling	Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.

Timeline

• Start date: 2018-07-16
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2018-07-27
• Last updated: 2023-11-15

Locations

5 sites across 1 country: Switzerland