Tension-Type HeadacheNCT07779655
Tension-type Headache and Its Association
An observational study of Tension-Type Headache and Sleep Disturbance, run by Assiut University.
Trial summary
To estimate the prevalence of tension-type headache among adults attending the outpatient clinics at Assiut University Hospitals, and to assess its association with smartphone use, sleep quality, and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tension-Type Headache, Sleep Disturbance, Smartphone Addiction
- How many people
- 199 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2026to 10 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults aged 18-60 years attending the outpatient clinics of Assiut University Hospitals who meet the study eligibility criteria.
Who may be able to join
- Adults aged 18-60 years
- Attending the outpatient clinics at Assiut University Hospitals during the study period
- Able to understand the study questionnaires and provide informed consent
- No severe psychiatric illness or cognitive impairment interfering with questionnaire completion
- No serious medical illness that may affect participation
Who cannot join
- History of major neurological diseases (e.g., stroke, epilepsy, brain tumors)
- History of secondary headache disorders
- History of migraine or other primary headache disorders according to ICHD-3 criteria
- Refusal to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Tension-type Headache and Its Association With Smartphone Use,Sleep Quality and Quality of Life
To estimate the prevalence of tension-type headache among adults attending the outpatient clinics at Assiut University Hospitals, and to assess its association with smartphone use, sleep quality, and quality of life.
Read the detailed description
Tension-type headache (TTH) is the most prevalent primary headache disorder and one of the most common neurological disorders. It is characterized by recurrent episodes of mild to moderate headache that are typically bilateral, pressing or tightening in quality, and is not aggravated by routine physical activity. Unlike migraine, TTH is usually not accompanied by nausea or vomiting, although either photophobia or phonophobia may be present. The diagnosis of TTH is based on the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.
Tension-type headache is classified according to attack frequency into three main types:
- Infrequent episodic tension-type headache (IETTH): headache occurs on less than one day per month on average (fewer than 12 days per year).
- Frequent episodic tension-type headache (FETTH): headache occurs on 1 to 14 days per month on average for more than three months (12 to 179 days per year).
- Chronic tension-type headache (CTTH): headache occurs on 15 or more days per month for more than three months (at least 180 days per year). This subtype is associated with greater disability and a more substantial impact on daily functioning and quality of life.
There is a strong association between tension-type headache and smartphone use. There is also increasing evidence for the association of TTH with sleep quality, causing sleep disturbances including insomnia, poor sleep quality, excessive daytime sleepiness, and insufficient sleep. However, there are limited studies in Egypt that have examined the associations between tension-type headache, smartphone use, sleep quality, and quality of life.
- Medical subject headings
- Tension-Type Headache, Parasomnias, Internet Addiction Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Tension-type Headache (TTH) among Adults
Number of adults with tension-type headache diagnosed according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria among those attending the outpatient clinics at Assiut University Hospitals.
Measured: 1year
Secondary outcomes (3)
Association between Tension-type Headache (TTH) and Smartphone Use
Association between tension-type headache and smartphone use assessed by a structured questionnaire on smartphone usage patterns.
Measured: 1year
Association between Tension-type Headache (TTH) and Sleep Quality
Association between tension-type headache and sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 19-item questionnaire with a global score ranging from 0 to 21, where higher scores indicate worse sleep quality.
Measured: 1 year
Impact of Tension-type Headache (TTH) on Quality of Life
Impact of tension-type headache on quality of life assessed by the Short Form-36 Health Survey (SF-36). The SF-36 has scores ranging from 0 to 100, where higher scores indicate better quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start10 Aug 2026 (estimated)
- Primary completion10 Nov 2027 (estimated)
- Study completion10 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 199 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmeen Yahia Kamal, Assiut University
- Investigators
- Dalia Mahran, prof, Study chair, assiutGhaydaa Shehata, prof, Study chair, assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779655
- Sponsor's protocol ID
- Tension-type headache
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949Pan LH, Ling YH, Wang SJ, Al-Hassany L, Chen WT, Chiang CC, Cho SJ, Chu MK, Coppola G, Pietra AD, Dong Z, Ekizoglu E, Els C, Farham F, Garcia-Azorin D, Ha WS, Hsiao FJ, Ishii R, Kim BK, Kissani N, Labastida-Ramirez A, Lange KS, Lytvyak E, Onan D, Ozge A, Papetti L, Pellesi L, Raffaelli B, Raggi A, Straube S, Takizawa T, Tanprawate S, Uluduz DU, Vongvaivanich K, Waliszewska-Prosol M, Wang Y, Wijeratne T, Wu JW, Yener SM, Martelletti P. Hallmarks of primary headache: part 2- Tension-type headache. J Headache Pain. 2025 Jul 17;26(1):164. doi: 10.1186/s10194-025-02098-w.
PubMed 40676501Mohamed RG, Sarhan K, Kamel B, Almetwaly RM, Fouda EE, Meshref M, Bioumy S, Alemam D, Ahmed HA. Prevalence and characteristics of headache among medical students in Egypt: a multicentric cross-sectional study. BMJ Neurol Open. 2024 Oct 15;6(2):e000851. doi: 10.1136/bmjno-2024-000851. eCollection 2024.
PubMed 39415897Argren MB, Engstrand H, Husoy AK, Kristoffersen ES, Toft M, Pripp AH, Zwart JA, Winsvold BS. Prevalence of headache disorders in Norway: results from the population based PopHEAD study. J Headache Pain. 2025 Nov 26;26(1):271. doi: 10.1186/s10194-025-02216-8.
PubMed 41299259
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tension-type Headache and Its Association With Smartphone Use,Sleep Quality and Quality of Life
- ClinicalTrials.gov ID
- NCT07779655
- Acronym / sponsor ID
- Tension-type headache
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 199 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 10 Nov 2027 (estimated)
- Study completion
- 10 Aug 2028 (estimated)
- First posted
- 21 Aug 2026 (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.
To estimate the prevalence of tension-type headache among adults attending the outpatient clinics at Assiut University Hospitals, and to assess its association with smartphone use, sleep quality, and quality of life.
Detailed description
Tension-type headache (TTH) is the most prevalent primary headache disorder and one of the most common neurological disorders. It is characterized by recurrent episodes of mild to moderate headache that are typically bilateral, pressing or tightening in quality, and is not aggravated by routine physical activity. Unlike migraine, TTH is usually not accompanied by nausea or vomiting, although either photophobia or phonophobia may be present. The diagnosis of TTH is based on the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.
Tension-type headache is classified according to attack frequency into three main types:
- Infrequent episodic tension-type headache (IETTH): headache occurs on less than one day per month on average (fewer than 12 days per year).
- Frequent episodic tension-type headache (FETTH): headache occurs on 1 to 14 days per month on average for more than three months (12 to 179 days per year).
- Chronic tension-type headache (CTTH): headache occurs on 15 or more days per month for more than three months (at least 180 days per year). This subtype is associated with greater disability and a more substantial impact on daily functioning and quality of life.
There is a strong association between tension-type headache and smartphone use. There is also increasing evidence for the association of TTH with sleep quality, causing sleep disturbances including insomnia, poor sleep quality, excessive daytime sleepiness, and insufficient sleep. However, there are limited studies in Egypt that have examined the associations between tension-type headache, smartphone use, sleep quality, and quality of life.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults aged 18-60 years attending the outpatient clinics of Assiut University Hospitals who meet the study eligibility criteria.
Key inclusion criteria (5 listed)
- Adults aged 18-60 years
- Attending the outpatient clinics at Assiut University Hospitals during the study period
- Able to understand the study questionnaires and provide informed consent
- No severe psychiatric illness or cognitive impairment interfering with questionnaire completion
- No serious medical illness that may affect participation
Key exclusion criteria (4 listed)
- History of major neurological diseases (e.g., stroke, epilepsy, brain tumors)
- History of secondary headache disorders
- History of migraine or other primary headache disorders according to ICHD-3 criteria
- Refusal to participate
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
Prevalence of Tension-type Headache (TTH) among Adults
Time frame: 1year
Number of adults with tension-type headache diagnosed according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria among those attending the outpatient clinics at Assiut University Hospitals.
3 secondary outcomes
Association between Tension-type Headache (TTH) and Smartphone Use
Time frame: 1year
Association between Tension-type Headache (TTH) and Sleep Quality
Time frame: 1 year
Impact of Tension-type Headache (TTH) on Quality of Life
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 29368949Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- Background: PubMed 40676501Pan LH, Ling YH, Wang SJ, Al-Hassany L, Chen WT, Chiang CC, Cho SJ, Chu MK, Coppola G, Pietra AD, Dong Z, Ekizoglu E, Els C, Farham F, Garcia-Azorin D, Ha WS, Hsiao FJ, Ishii R, Kim BK, Kissani N, Labastida-Ramirez A, Lange KS, Lytvyak E, Onan D, Ozge A, Papetti L, Pellesi L, Raffaelli B, Raggi A, Straube S, Takizawa T, Tanprawate S, Uluduz DU, Vongvaivanich K, Waliszewska-Prosol M, Wang Y, Wijeratne T, Wu JW, Yener SM, Martelletti P. Hallmarks of primary headache: part 2- Tension-type headache. J Headache Pain. 2025 Jul 17;26(1):164. doi: 10.1186/s10194-025-02098-w.
- Background: PubMed 39415897Mohamed RG, Sarhan K, Kamel B, Almetwaly RM, Fouda EE, Meshref M, Bioumy S, Alemam D, Ahmed HA. Prevalence and characteristics of headache among medical students in Egypt: a multicentric cross-sectional study. BMJ Neurol Open. 2024 Oct 15;6(2):e000851. doi: 10.1136/bmjno-2024-000851. eCollection 2024.
- Background: PubMed 41299259Argren MB, Engstrand H, Husoy AK, Kristoffersen ES, Toft M, Pripp AH, Zwart JA, Winsvold BS. Prevalence of headache disorders in Norway: results from the population based PopHEAD study. J Headache Pain. 2025 Nov 26;26(1):271. doi: 10.1186/s10194-025-02216-8.
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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.
Dalia Mahran, prof study chair
assiut
Ghaydaa Shehata, prof study chair
assiut
Questions about this trial
What is this clinical trial studying?
An observational study of Tension-Type Headache and Sleep Disturbance, run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmeen Kamal, residant (01285297205, Jasmine.18323171@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Tension-type Headache (TTH) among Adults (time frame: 1year). 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 NCT07779655, which also lists 4 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 24 Aug 2026.