AzTrials
AzTrials

Smoking CessationESTxENDSNCT03603353

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

A study testing ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling in people with Smoking Cessation and Sleep, run by University of Bern at 5 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation, Sleep
What is being tested?
ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,246 participants
Where
5 sitesSwitzerland
Study dates
16 Jul 2018to 31 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Informed Consent as documented by signature
  • Persons aged 18 or older
  • Currently smoking 5 or more cigarettes a day for at least 12 months
  • Willing to try to quit smoking within the next 3 months,
  • Persons providing a valid phone number, a valid email address and/or a valid postal address.

Who cannot join

  • Known hypersensitivity or allergy to contents of the e-liquid
  • Participation in another study with investigational drug within the 30 days preceding the baseline visit and during the present study where interactions are to be expected
  • Women who are pregnant or breast feeding
  • Intention to become pregnant during the course of the scheduled study intervention, i.e. within the first 6-months of the study
  • Persons having used ENDS or tobacco heating systems regularly in the 3 months preceding the baseline visit
  • Persons having used nicotine replacement therapy (NRT) or other medications with demonstrated efficacy as an aid for smoking cessation such as varenicline or bupropion within the 3 months preceding the baseline visit
  • Persons who cannot attend the 6- month follow-up visit for any reason
  • Cannot understand instructions delivered in person or by phone, or otherwise unable to participate in study procedures

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Switzerland5 sites

  • University Clinic for General Internal Medicine, Bern University Hospital

    Bern, 3010

  • Département de médecine interne, Hôpitaux universitaires de Genève

    Geneva, 1211

  • Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne

    Lausanne, Canton of Vaud, 1011

  • Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen

    Sankt Gallen

  • Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich

    Zurich

Other trials in Switzerland

About this study

Official title: 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

--> 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.

Read more

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.

Being tested
ENDS (vaporizer/e-cig) and smoking cessation counseling, Smoking cessation counseling
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ENDS (vaporizer/e-cig) and smoking cessation counselingOther

    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.

  • Smoking cessation counselingOther

    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.

Study groups in NCT03603353
Study groupRoleWhat they receive
Intervention groupExperimentalNot described
Receives: Other: ENDS (vaporizer/e-cig) and smoking cessation counseling
Control groupActive comparatorNot described
Receives: Other: Smoking cessation counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective sleep quality_1

    Subjective sleep quality assessed with the Pittsburgh Sleep Quality Index (PSQI).

    Measured: 6 months post quit date

  2. Subjective sleep quality_2

    Subjective sleep quality assessed with the Pittsburgh Sleep Quality Index (PSQI).

    Measured: 12 months post quit date

  3. Subjective sleep quality_3

    Subjective sleep quality assessed with the Pittsburgh Sleep Quality Index (PSQI).

    Measured: 24 months post quit date

Secondary outcomes (1)

  1. Change in subjective sleep quality

    Subjective sleep quality assessed with the Pittsburgh Sleep Quality Index (PSQI).

    Measured: Change from baseline to 6,12, 24 months post quit date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2018
  2. Study start16 Jul 2018
  3. Primary completion31 Aug 2023
  4. Study completion31 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03603353
Sponsor's protocol ID
2017-02332g
Other IDs
2017
Acronym
ESTxENDS
Status last verified
Nov 2023
First submitted
2 Jul 2018
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hughes JR. Effects of abstinence from tobacco: etiology, animal models, epidemiology, and significance: a subjective review. Nicotine Tob Res. 2007 Mar;9(3):329-39. doi: 10.1080/14622200701188927.

    PubMed 17365765

  • Hughes JR, Higgins ST, Bickel WK. Nicotine withdrawal versus other drug withdrawal syndromes: similarities and dissimilarities. Addiction. 1994 Nov;89(11):1461-70. doi: 10.1111/j.1360-0443.1994.tb03744.x.

    PubMed 7841857

  • Wetter DW, Young TB. The relation between cigarette smoking and sleep disturbance. Prev Med. 1994 May;23(3):328-34. doi: 10.1006/pmed.1994.1046.

    PubMed 8078854

  • Colrain IM, Trinder J, Swan GE. The impact of smoking cessation on objective and subjective markers of sleep: review, synthesis, and recommendations. Nicotine Tob Res. 2004 Dec;6(6):913-25. doi: 10.1080/14622200412331324938.

    PubMed 15801567

  • Bertrand D. The possible contribution of neuronal nicotinic acetylcholine receptors in depression. Dialogues Clin Neurosci. 2005;7(3):207-16. doi: 10.31887/DCNS.2005.7.3/dbertrand.

    PubMed 16156379

  • Grandner MA, Jackson NJ, Pak VM, Gehrman PR. Sleep disturbance is associated with cardiovascular and metabolic disorders. J Sleep Res. 2012 Aug;21(4):427-33. doi: 10.1111/j.1365-2869.2011.00990.x. Epub 2011 Dec 12.

    PubMed 22151079

Questions about this trial

What is this clinical trial studying?

A study testing ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling in people with Smoking Cessation and Sleep, run by University of Bern at 5 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective sleep quality_1 (time frame: 6 months post quit date). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03603353, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in