- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07765849
Online Sleep Education for College Student's Sleep Health and Executive Functioning
The Role of Sleep Education in Improving Sleep Quality, Executive Functioning, and Sleep Health Literacy
The goal of this clinical trial is to determine if asynchronous psychoeducational sleep intervention works to improve college students' levels of self-reported sleep health literacy, sleep quality, and executive functioning.
The main questions it aims to answer are:
Can an educational sleep intervention improve college students' sleep health literacy and sleep quality? Does improved sleep health literacy impact sleep quality? Does improved sleep improve executive functioning in a college student sample?
The hypotheses of the present study include the following:
- College students with poor sleep quality will have lower executive functioning
- College students who participate in a brief educational sleep intervention will have more improvements in sleep health literacy compared to college students who do not
- College students who participate in a brief educational sleep intervention will have more improvements in sleep quality compared to college students who do not
- College students who participate in a brief educational sleep intervention will have more improvements in executive functioning compared to college students who do not.
Researchers will compare the intervention group to a wait-list control group to see if college students who watch the psychoeducational sleep intervention have more improvements in sleep quality, sleep health literacy, and executive functioning than those who do not.
Participants will:
- Complete a pre-intervention survey
- Respond to a post-intervention survey six weeks after the pre-intervention survey
- Be randomly assigned to watch a 30-to 45-minute psychoeducational sleep lecture video either during the pre-intervention survey or after the post-intervention survey
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Kiley D Hawkins, B.S.
- Telefonnummer: 623-241-2334
- E-post: kh2874@nau.edu
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Be at least 18 years old
- Be currently enrolled as an undergraduate student in a U.S. college or university
- Have English language proficiency
- Have internet access
- Have an electronic device to complete an online survey
Exclusion Criteria:
- Having a diagnosed sleep-wake disorder
- Having a history of treatment for sleep difficulties
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Wait-List Control Group
The wait-list control group will not receive the 30-to 45-minute psychoeducational sleep lecture video prior to completing post-intervention surveys.
Participants assigned to this arm will be granted access to the intervention at the conclusion of the post-intervention survey.
|
|
|
Experimentell: Psychoeducational Sleep Intervention
Participants assigned to this arm will undergo a 30-to 45-minute psychoeducational sleep lecture video.
This video will be embedded in the pre-intervention survey packet.
|
The present study uses a 30-to 45-minute psychoeducational sleep lecture that is tailored to college students.
The lecture reviews topics such as sleep information, trends among college students, and consequences of poor sleep (e.g., on psychosocial, cognitive, and academic functioning).
The lecture also includes information about sleep hygiene and stimulus control instructions to provide students with resources for implementing adaptive sleep hygiene behaviors that promote better sleep and functioning.
This intervention will be embedded within the pre-intervention survey packet for participants who are randomly assigned to the intervention arm.
Participants assigned to the no intervention arm will be granted access to the intervention at the conclusion of the post-intervention survey packet.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pittsburgh Sleep Quality Index
Tidsram: This will be administered at enrollment (pre-intervention), and again in 6-weeks (post-intervention)
|
This is a 19-item self-report questionnaire used to assess sleep quality, sleep onset latency, total duration, sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction.
|
This will be administered at enrollment (pre-intervention), and again in 6-weeks (post-intervention)
|
|
Barkely Deficits in Executive Functioning-Short Form
Tidsram: This will be administered at enrollment (pre-intervention), and again in 6-weeks (post-intervention)
|
This is a 20-item self-report questionnaire that measures deficits in time management, organization, problem solving, self-restraint, self-motivation, and emotion regulation.
|
This will be administered at enrollment (pre-intervention), and again in 6-weeks (post-intervention)
|
|
Sleep Health Literacy Scale
Tidsram: This will be administered at enrollment (pre-intervention), and again in 6-weeks (post-intervention)
|
This is a 61-item self-report questionnaire used to measure sleep health communication and sleep health knowledge.
|
This will be administered at enrollment (pre-intervention), and again in 6-weeks (post-intervention)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Behavior Change Questions
Tidsram: This will be administered at enrollment (pre-intervention), and again in 6-weeks (post-intervention)
|
These are questions developed by the researcher to assess participants' perceptions of their sleep, knowledge of sleep and sleep hygiene, and their ability to manage day-to-day tasks.
These questions will also inquire about specific behavioral/sleep hygiene changes participants intend to make and any barriers to implementing the changes.
|
This will be administered at enrollment (pre-intervention), and again in 6-weeks (post-intervention)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Marie-Christine Goodworth, PhD, Northern Arizona University
- Huvudutredare: Kiley D Hawkins, B.S., Northern Arizona University
Publikationer och användbara länkar
Allmänna publikationer
- Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, Dinges DF, Gangwisch J, Grandner MA, Kushida C, Malhotra RK, Martin JL, Patel SR, Quan SF, Tasali E. Recommended Amount of Sleep for a Healthy Adult: A Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society. Sleep. 2015 Jun 1;38(6):843-4. doi: 10.5665/sleep.4716.
- Troynikov O, Watson CG, Nawaz N. Sleep environments and sleep physiology: A review. J Therm Biol. 2018 Dec;78:192-203. doi: 10.1016/j.jtherbio.2018.09.012. Epub 2018 Oct 5.
- Brown FC, Buboltz WC Jr, Soper B. Development and evaluation of the Sleep Treatment and Education Program for Students (STEPS). J Am Coll Health. 2006 Jan-Feb;54(4):231-7. doi: 10.3200/JACH.54.4.231-237.
- Hershner SD, Chervin RD. Causes and consequences of sleepiness among college students. Nat Sci Sleep. 2014 Jun 23;6:73-84. doi: 10.2147/NSS.S62907. eCollection 2014.
- Parrilla MM, Kautiainen RJ, King TZ. Sleep quality and executive function in a diverse sample of healthy young adults. Appl Neuropsychol Adult. 2025 Nov-Dec;32(6):1634-1642. doi: 10.1080/23279095.2023.2297299. Epub 2024 Jan 3.
- Barkley, R. A. (2011). Barkley Deficits in Executive Functioning (BDEFS for Adults). Guilford Publications.
- Becerra MB, Bol BS, Granados R, Hassija C. Sleepless in school: The role of social determinants of sleep health among college students. J Am Coll Health. 2020 Feb-Mar;68(2):185-191. doi: 10.1080/07448481.2018.1538148. Epub 2018 Nov 29.
- Billings ME, Cohen RT, Baldwin CM, Johnson DA, Palen BN, Parthasarathy S, Patel SR, Russell M, Tapia IE, Williamson AA, Sharma S. Disparities in Sleep Health and Potential Intervention Models: A Focused Review. Chest. 2021 Mar;159(3):1232-1240. doi: 10.1016/j.chest.2020.09.249. Epub 2020 Sep 30.
- Nelson KL, Davis JE, Corbett CF. Sleep quality: An evolutionary concept analysis. Nurs Forum. 2022 Jan;57(1):144-151. doi: 10.1111/nuf.12659. Epub 2021 Oct 5.
- Ohayon M, Wickwire EM, Hirshkowitz M, Albert SM, Avidan A, Daly FJ, Dauvilliers Y, Ferri R, Fung C, Gozal D, Hazen N, Krystal A, Lichstein K, Mallampalli M, Plazzi G, Rawding R, Scheer FA, Somers V, Vitiello MV. National Sleep Foundation's sleep quality recommendations: first report. Sleep Health. 2017 Feb;3(1):6-19. doi: 10.1016/j.sleh.2016.11.006. Epub 2016 Dec 23.
- Hackney JE, Weaver TE, Pack AI. Health literacy and sleep disorders: a review. Sleep Med Rev. 2008 Apr;12(2):143-51. doi: 10.1016/j.smrv.2007.07.002. Epub 2008 Jan 25.
- American College Health Association. (2024). American College Health Association- National College Health Assessment II: Undergraduate Student Reference Group Data Report Spring 2024 [Report].
- American College Health Association. (2018). American College Health Association- National College Health Assessment II: Undergraduate Student Reference Group Data Report Spring 2018 [Report].
- Feldman EL, Slavish DC. Initial development of a sleep health literacy scale. Sleep Health. 2024 Dec;10(6):683-690. doi: 10.1016/j.sleh.2024.08.001. Epub 2024 Sep 26.
- Pantesco EJ, Kan IP. False beliefs about sleep and their associations with sleep-related behavior. Sleep Health. 2022 Apr;8(2):216-224. doi: 10.1016/j.sleh.2021.10.004. Epub 2021 Nov 26.
- Gellis LA, Lichstein KL. Sleep hygiene practices of good and poor sleepers in the United States: an internet-based study. Behav Ther. 2009 Mar;40(1):1-9. doi: 10.1016/j.beth.2008.02.001. Epub 2008 Jul 14.
- Brown, F. C., & Buboltz, W. C., Jr. (2002). Applying sleep research to university students: Recommendations for developing a student sleep education program. Journal of College Student Development, 43(3), 411-416.
- Brown FC, Buboltz WC Jr, Soper B. Relationship of sleep hygiene awareness, sleep hygiene practices, and sleep quality in university students. Behav Med. 2002 Spring;28(1):33-8. doi: 10.1080/08964280209596396.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2441114-2
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .