Digital AddictionNCT06738524
Digital Addiction, Sleep Quality and Orexin-A Level
A study testing Fighting with Digital Addiction in people with Digital Addiction, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the level of digital addiction in university students where technology use is quite common, and to evaluate the relationship between digital addiction and orexin and sleep quality. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Digital Addiction
- What is being tested?
- Fighting with Digital Addiction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Aug 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals studying at Amasya University,
- Those who agree to participate in the study,
- Individuals who do not have any communication barriers
Who cannot join
- Individuals who are not students at Amasya University,
- Individuals with communication disabilities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Digital Addiction on Orexin a Peptide and Sleep Quality
This study aims to determine the level of digital addiction in university students where technology use is quite common, and to evaluate the relationship between digital addiction and orexin and sleep quality.
The main question it aims to answer is:
- Are digital addiction trainings given to students effective on digital addiction levels?
- Are digital addiction trainings given to students effective on sleep quality?
- Is there a relationship between digital addiction level and orexin-A peptide?
Read the detailed description
The changes experienced in technology along with the developing world also bring about major changes in the lives of individuals. It is seen that technology is present in every aspect of life, especially the internet that enables widespread communication and the use of the tools and equipment developed accordingly is rapidly increasing especially in the young age group. It is stated that digital addiction is spreading very rapidly throughout the world and has many negative consequences on the daily life and health of the individual. Many health problems such as personality disorders, violence, increase in aggressive behavior, disruptions in the sleep-wake cycle, anxiety, and depression are associated with digital addiction. Orexins are hypothalamic neuropeptides that play a role in the regulation of many complex behaviors such as nutrition, sleep, and wakefulness. In recent studies, it is thought that orexin can cause behavioral addictions. Orexin plays a role in both the early and late stages of the addiction mechanism.
- Conditions
- Digital Addiction
- Being tested
- Fighting with Digital Addiction
- Keywords
- Digital addiction, Orexin-A, Sleep quality, Technology
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fighting with Digital AddictionBehavioural
The purpose of this training is to raise awareness among young people about the signs, causes and consequences of addictive use of technology and how to avoid excessive use of technology and technology addiction.
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | The intervention group was given "Fighting with Digital Addiction" training. Receives: Behavioral: Fighting with Digital Addiction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Addiction Scale
A positive change in participants' digital addiction scores is expected at the end of the training program.
Measured: 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Feb 2024
- Primary completion1 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Digital AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- The research was conducted in two stages. In the first stage, the "Pittsburgh Sleep Quality Index" and "Digital Addiction Scale" were applied to all students. In the second stage, the experimental and control groups were created by analyzing the scores of the students from the Digital Addiction Scale for the intervention study. It was calculated with the power analysis that 42 participants should be included in the study. 21 participants were randomly assigned to the intervention group and 21 participants to the control group by lot. Blood samples were taken from the students assigned to the intervention and control groups before the training and their orexin-A levels were measured. Then, the digital addiction combating training program was applied to the intervention group. After the training program was completed, a post-test was applied to both groups and orexin-A levels were measured again.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Incedal Sonkaya, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738524
- Sponsor's protocol ID
- 182210
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sonkaya ZI, Yazgan B. The Effect of Digital Addiction Training on University Students' Digital Addiction, Sleep Quality, and Orexin-A Levels: Randomized Controlled Trial. BMC Psychol. 2025 Aug 12;13(1):903. doi: 10.1186/s40359-025-03247-1.
PubMed 40797228
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Digital Addiction on Orexin a Peptide and Sleep Quality
- ClinicalTrials.gov ID
- NCT06738524
- Acronym / sponsor ID
- 182210
- Conditions
- Digital Addiction
- Keywords
- Digital addiction, Orexin-A, Sleep quality, Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the level of digital addiction in university students where technology use is quite common, and to evaluate the relationship between digital addiction and orexin and sleep quality.
The main question it aims to answer is:
- Are digital addiction trainings given to students effective on digital addiction levels?
- Are digital addiction trainings given to students effective on sleep quality?
- Is there a relationship between digital addiction level and orexin-A peptide?
Detailed description
The changes experienced in technology along with the developing world also bring about major changes in the lives of individuals. It is seen that technology is present in every aspect of life, especially the internet that enables widespread communication and the use of the tools and equipment developed accordingly is rapidly increasing especially in the young age group. It is stated that digital addiction is spreading very rapidly throughout the world and has many negative consequences on the daily life and health of the individual. Many health problems such as personality disorders, violence, increase in aggressive behavior, disruptions in the sleep-wake cycle, anxiety, and depression are associated with digital addiction. Orexins are hypothalamic neuropeptides that play a role in the regulation of many complex behaviors such as nutrition, sleep, and wakefulness. In recent studies, it is thought that orexin can cause behavioral addictions. Orexin plays a role in both the early and late stages of the addiction mechanism.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The research was conducted in two stages. In the first stage, the "Pittsburgh Sleep Quality Index" and "Digital Addiction Scale" were applied to all students. In the second stage, the experimental and control groups were created by analyzing the scores of the students from the Digital Addiction Scale for the intervention study. It was calculated with the power analysis that 42 participants should be included in the study. 21 participants were randomly assigned to the intervention group and 21 participants to the control group by lot. Blood samples were taken from the students assigned to the intervention and control groups before the training and their orexin-A levels were measured. Then, the digital addiction combating training program was applied to the intervention group. After the training program was completed, a post-test was applied to both groups and orexin-A levels were measured again.
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: Fighting with Digital AddictionThe intervention group was given "Fighting with Digital Addiction" training. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals studying at Amasya University,
- Those who agree to participate in the study,
- Individuals who do not have any communication barriers
Key exclusion criteria (2 listed)
- Individuals who are not students at Amasya University,
- Individuals with communication disabilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fighting with Digital AddictionThe purpose of this training is to raise awareness among young people about the signs, causes and consequences of addictive use of technology and how to avoid excessive use of technology and technology addiction. | Behavioural | Education |
Primary outcome
Digital Addiction Scale
Time frame: 4 weeks.
A positive change in participants' digital addiction scores is expected at the end of the training program.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Derived from this study: PubMed 40797228Sonkaya ZI, Yazgan B. The Effect of Digital Addiction Training on University Students' Digital Addiction, Sleep Quality, and Orexin-A Levels: Randomized Controlled Trial. BMC Psychol. 2025 Aug 12;13(1):903. doi: 10.1186/s40359-025-03247-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fighting with Digital Addiction in people with Digital Addiction, run by Amasya University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Digital Addiction Scale (time frame: 4 weeks.). 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 NCT06738524, which also lists 1 linked publication.
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 17 Dec 2024.