Respiratory Effects of E-Cigarettes Among Youth / Young Adults

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StatussVēl nepieņem darbā

Sponsori

University of Oklahoma

Līdzstrādnieki

National Heart, Lung, and Blood Institute (NHLBI)

Food and Drug Administration (FDA)

KLĪNISKĀ IZPĒTE: NCT04395274

BioSeek: nct04395274

Atslēgvārdi

Abstrakts

E-cigarette (EC) use continues to increase among youth, and EC may be detrimental to youth respiratory health. Public health officials and the Food and Drug Administration (FDA) can now regulate ECs. The proposed study uses an in-laboratory and naturalistic assessments called ecological momentary assessment to understand how ECs use may impact the respiratory health of youth and young adult users compared to never-using peers.

Apraksts

Using a 1-year, prospective longitudinal design, 150 youth and young adults aged 15-21 years (100 exclusive-EC users; 50 never-users) will complete 5 laboratory visits (baseline, 3-,6-, 9-, and 12-months) following >12 hours of abstinence, which will include laboratory-based respiratory assessments of airway reactivity, inflammation, and spirometry. All participants will also provide salivary samples for bio-confirmation of nicotine (cotinine). To assess acute changes in pulmonary functioning related to tobacco product use, participants will complete twice daily EMA "bursts" and home-based spirometry for the 2-weeks prior to each follow-up laboratory visit. EC users' puff topography will also be assessed at all laboratory visits during a 30-minute ad libitum EC puffing session, to examine the association between total inhaled volume and self-reported nicotine dependence and respiratory health.

Datumi

Pēdējoreiz pārbaudīts:	04/30/2020
Pirmais iesniegtais:	04/20/2020
Paredzētā reģistrācija iesniegta:	05/13/2020
Pirmais izlikts:	05/19/2020
Pēdējais atjauninājums iesniegts:	05/13/2020
Pēdējā atjaunināšana ievietota:	05/19/2020
Faktiskais studiju sākuma datums:	07/31/2020
Paredzamais primārās pabeigšanas datums:	09/30/2023
Paredzamais pētījuma pabeigšanas datums:	06/30/2024

Stāvoklis vai slimība

E Cig Use

Fāze

Roku grupas

Roka	Iejaukšanās / ārstēšana
Current E-Cigarette Users Monitoring current e-cigarette users
Never E-Cigarette / Tobacco Users Monitoring never users of any tobacco or e-cigarette products.

Atbilstības kritēriji

Vecums, kas piemērots studijām	15 Years Uz 15 Years
Dzimumi, kas ir piemēroti studijām	All
Paraugu ņemšanas metode	Non-Probability Sample
Pieņem veselīgus brīvprātīgos	Jā
Kritēriji	Inclusion Criteria: 1. have parental consent to participate 2. own a smartphone and willing to add study EMA and spirometry application to it. 3. a current exclusive-EC user (endorse ≥weekly use over the past 3 months) and report never trying OTPs 4. between the ages of 15-21 years old at the time of enrollment 5. willing to provide informed consent and abstain from all tobacco and nicotine use for at least 12 hours prior to the five lab sessions 6. willing to complete four, 2-week periods of daily EMA and home-based spirometry 7. read and speak English 8. never-users must indicate never trying any tobacco product to be eligible for enrollment Exclusion Criteria: 1. self-reported diagnosis of lung disease including cystic fibrosis or chronic obstructive pulmonary disease 2. unstable or significant psychiatric conditions (past and stable conditions will be allowed) 3. history of cardiac event or distress within the past 3 months 4. are currently pregnant, planning to become pregnant, or breastfeeding

Rezultāts

Primārie rezultāti

1. Spirometry to measure the change from baseline in forced vital capacity (FVC) and forced expiratory volume (FEV) over a 12-month time period in 3-month increments. [Baseline, 3-month, 6-month, 9- month, 12-month]

Computer based spirometry (a pulmonary function diagnostic test) will be completed during each laboratory session. For e-cigarette users, assessments will be completed before (pre) and after (post) in-lab vaping session.

2. Change in Exhaled Nitric Oxide from baseline over a 12-month time period in 3-month increments. [Baseline, 3-month, 6-month, 9- month, 12-month]

Exhaled nitric oxide will be completed during each laboratory sessions. For e-cigarette users, assessments will be completed before (pre) and one after (post) in-lab vaping session.

3. Change in Airway Reactivity using airway oscillometry (Tremoflo) from baseline over a 12-month time period in 3-month increments. [Baseline, 3-month, 6-month, 9- month, 12-month]

Computer based airway reactivity will be completed during each laboratory session to test for airway responses to vaping. For e-cigarette users, assessments will be completed pre and post in lab vaping session.

4. Change in level of e-cigarette aerosol inhalation measured with a Topography device from baseline over a 12-month time period in 3-month increments. [Baseline, 3-month, 6-month, 9- month, 12-month]

This will be completed by e-cigarette users only during the vaping session. Users will bring their own device and the amount of aerosol inhaled and the time it takes to complete one inhalation from an e-cigarette device.

5. Change in Salivary Cotinine from baseline over a 12-month time period in 3-month increments. [Baseline, 3-month, 6-month, 9- month, 12-month]

All participants will provide saliva to examine biological markers for nicotine. Biomarkers will be evaluated over time to assess changes to cotinine levels over a 12-month time frame.

6. Changes in product use evaluated over a 12-month time period in 3 month increments with an evaluation of the changes in dependence over a 12 month period evaluated in 3-month increments using the Hooked on Nicotine Checklist (HONC). [Baseline, 3-month, 6-month, 9- month, 12-month]

Dependence by product type will be examined throughout the monitoring period.