Respiratory Function TestsNCT05847127
Is There a Difference in Pulmonary Functions and Craniovertebral Angle Among Adolescent Based on Smart Phone Usage
An observational study of Respiratory Function Tests, run by Maryan Mamdouh Fayez at 1 site in Egypt.
Trial summary
The smartphones have become a necessity for most adolescents as they are used for communication and entertainment and education purposes especially in the period of COVID pandemic. They spend most of their time in using smartphones. This could have side effects on their health. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Function Tests
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2023to Oct 2023
- Phase
- Observational
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Well-developed adolescents of both genders.
Who may be able to join
- Subjects of late childhood ( adolescence)
- Age of participants ranged from 14 to 18 years.
- Subjects with normal development.
Who cannot join
- Athletic one.
- Genetic spinal deformity.
- Injury to the neck.
- History of inflammatory joint disease.
- History of surgical intervention at the neck. Patients with neuropediatric problem.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is There a Difference in Pulmonary Functions and Craniovertebral Angle Among Adolescent Based on Their Smart Phone Usage Time? A Cross Sectional Study
The smartphones have become a necessity for most adolescents as they are used for communication and entertainment and education purposes especially in the period of COVID pandemic. They spend most of their time in using smartphones. This could have side effects on their health.
While using a smartphone, adolescent usually flex their neck and maintain the head in a forward position for long periods of time, which may affect the craniovertebral angle and pulmonary functions as sustained forward neck posture may lead to respiratory dysfunction.The purpose of the study is to investigate the effect of smart phones and tablets usage time on craniovertebral angle and problems of pulmonary functions among adolescents between 14-18 years' old.
Read the detailed description
A well-developed adolescents of both genders will participate in this study after signing institutionally approved consent form prior to data collection
- They will be recruited from many secondary schools in Cairo. Their ages range from 14 to 18 years. They will be subdivided into two groups according to Smartphone addiction scale-short version (SAS-SV) into an addict group who use smart phone not less than 4 hours/day for at least 4 years and non-addict group who used smart phone less than that.
- Design of the study: Cross sectional design will be applied in this study.
- Smartphone addiction scale-short version (SAS-SV) will be used to divide the subjects into two groups addict and non-addict groups
- (Image J) image processing and analysis in Java system will be used to measure the craniovertebral angle for both groups.
- Micromedical Gold standard fully computerized portable auto spirometer will be used to measure Pulmonary functions test in the form of forced expiratory volume in one second (FEV1), forced vital capacity (FVC)and FEV1/FVC for both groups.
- All data will be recorded and statistically analysis.
- Conditions
- Respiratory Function Tests
- Keywords
- Pulmonary function, craniovertebral angle, smart phone usage
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function tests
FVC \& FEV1 both are measured in liters
Measured: Baseline
Craniovertebral angle
measured in degree
Measured: Baseline
Pulmonary function tests
FEV1/FVC measured in percentage ( % )
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start28 Feb 2023
- Primary completionAug 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Function TestsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maryan Mamdouh Fayez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maryan Mamdouh Fayez, Egyptian Chinese University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847127
- Sponsor's protocol ID
- P.T.REC/012/003908
- Status last verified
- Apr 2023
- First submitted
- 13 Feb 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Difference in Pulmonary Functions and Craniovertebral Angle Among Adolescent Based on Their Smart Phone Usage Time? A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05847127
- Acronym / sponsor ID
- P.T.REC/012/003908
- Conditions
- Respiratory Function Tests
- Keywords
- Pulmonary function, craniovertebral angle, smart phone usage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Maryan Mamdouh FayezUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 6 May 2023 (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.
The smartphones have become a necessity for most adolescents as they are used for communication and entertainment and education purposes especially in the period of COVID pandemic. They spend most of their time in using smartphones. This could have side effects on their health.
While using a smartphone, adolescent usually flex their neck and maintain the head in a forward position for long periods of time, which may affect the craniovertebral angle and pulmonary functions as sustained forward neck posture may lead to respiratory dysfunction.The purpose of the study is to investigate the effect of smart phones and tablets usage time on craniovertebral angle and problems of pulmonary functions among adolescents between 14-18 years' old.
Detailed description
A well-developed adolescents of both genders will participate in this study after signing institutionally approved consent form prior to data collection
- They will be recruited from many secondary schools in Cairo. Their ages range from 14 to 18 years. They will be subdivided into two groups according to Smartphone addiction scale-short version (SAS-SV) into an addict group who use smart phone not less than 4 hours/day for at least 4 years and non-addict group who used smart phone less than that.
- Design of the study: Cross sectional design will be applied in this study.
- Smartphone addiction scale-short version (SAS-SV) will be used to divide the subjects into two groups addict and non-addict groups
- (Image J) image processing and analysis in Java system will be used to measure the craniovertebral angle for both groups.
- Micromedical Gold standard fully computerized portable auto spirometer will be used to measure Pulmonary functions test in the form of forced expiratory volume in one second (FEV1), forced vital capacity (FVC)and FEV1/FVC for both groups.
- All data will be recorded and statistically analysis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Well-developed adolescents of both genders.
Key inclusion criteria (3 listed)
- Subjects of late childhood ( adolescence)
- Age of participants ranged from 14 to 18 years.
- Subjects with normal development.
Key exclusion criteria (5 listed)
- Athletic one.
- Genetic spinal deformity.
- Injury to the neck.
- History of inflammatory joint disease.
- History of surgical intervention at the neck. Patients with neuropediatric problem.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary function tests
Time frame: Baseline
FVC \& FEV1 both are measured in liters
Craniovertebral angle
Time frame: Baseline
measured in degree
Pulmonary function tests
Time frame: Baseline
FEV1/FVC measured in percentage ( % )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Respiratory Function Tests, run by Maryan Mamdouh Fayez at 1 site in Egypt.
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 5 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: status not confirmed, as of the sponsor's last update on 6 May 2023. 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 Egypt. 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?
Results are not available in the source record.
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?
Pulmonary function tests (time frame: Baseline). 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?
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 6 May 2023.