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Not yet recruitingNCT07779655Updated Aug 24, 2026

Tension-type Headache and Its Association

An observational study in Tension-Type Headache, Sleep Disturbance and Smartphone Addiction, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
199
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Tension-Type Headache
  • Sleep Disturbance
  • Smartphone Addiction
  • Quality of Life
03

In context

Tension-Type Headache

143 studies on the registry are indexed under Tension-Type Headache; 42 are open to participants now.

This study's planned enrollment of 199 is above the median of 165 across 30 observational studies indexed under Tension-Type Headache.

Browse Tension-Type Headache studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults aged 18-60 years attending the outpatient clinics of Assiut University Hospitals who meet the study eligibility criteria.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • No severe psychiatric illness or cognitive impairment interfering with questionnaire completion
  • No serious medical illness that may affect participation

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
199 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1year

Secondary outcomes

  1. 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.

    Time frame: 1year

  2. 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.

    Time frame: 1 year

  3. 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.

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

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 29368949 ↗
  • Pan 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 40676501 ↗
  • Mohamed 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 39415897 ↗
  • Argren 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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2026; primary completion for Nov 2027, 15 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2026
First posted
Aug 21, 2026
StartEst.
Aug 10, 2026
Primary completionEst.
Nov 10, 2027
CompletionEst.
Aug 10, 2028
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07779655
Lead sponsor
Assiut University
Responsible party
Yasmeen Yahia Kamal (Resident, Assiut University) — Principal investigator
First posted
Aug 21, 2026
Start date
Aug 10, 2026 (estimated)
Primary completion
Nov 10, 2027 (estimated)
Completion
Aug 10, 2028 (estimated)
Last update
Aug 24, 2026

Study contacts

Yasmeen Kamal, residant
Contact
Jasmine.18323171@med.aun.edu.eg
01285297205
Dalia Mahran, prof
study chair · assiut
Ghaydaa Shehata, prof
study chair · assiut

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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