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

Not Applicable

Completed

• Conditions: Sleep; Smoking Cessation
• Interventions: Other: Smoking cessation counseling; Other: ENDS (vaporizer/e-cig) and smoking cessation counseling

• Registration Number: NCT03603353
• Lead Sponsor: University of Bern

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-02
• Study Start: 2018-07-16
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-07-27
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1246

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Smoking cessation counseling	-
Intervention group	ENDS (vaporizer/e-cig) and smoking cessation counseling	-

Primary Outcome Measures

Name	Time	Method
Subjective sleep quality_1	6 months post quit date	Subjective sleep quality assessed with the Pittsburgh Sleep Quality Index (PSQI).
Subjective sleep quality_3	24 months post quit date	Subjective sleep quality assessed with the Pittsburgh Sleep Quality Index (PSQI).
Subjective sleep quality_2	12 months post quit date	Subjective sleep quality assessed with the Pittsburgh Sleep Quality Index (PSQI).

Secondary Outcome Measures

Name	Time	Method
Change in subjective sleep quality	Change from baseline to 6,12, 24 months post quit date	Subjective sleep quality assessed with the Pittsburgh Sleep Quality Index (PSQI).

Trial Locations

Locations (5)

Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich; 🇨🇭 Zürich, Switzerland

Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne; 🇨🇭 Lausanne, Vaud, Switzerland

University Clinic for General Internal Medicine, Bern University Hospital; 🇨🇭 Bern, Switzerland

Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen; 🇨🇭 Saint Gallen, Switzerland

Département de médecine interne, Hôpitaux universitaires de Genève; 🇨🇭 Geneva, Switzerland