Clinical Trial on Quality of Life, Sleep Disturbance, Tension-Type Headache, Smartphone Addiction - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Yasmeen Kamal, residant
Phone Number: 01285297205
Email: Jasmine.18323171@med.aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

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.

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between Tension-type Headache (TTH) and Smartphone Use Time Frame: 1year	Association between tension-type headache and smartphone use assessed by a structured questionnaire on smartphone usage patterns.	1year
Association between Tension-type Headache (TTH) and Sleep Quality Time Frame: 1 year	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.	1 year
Impact of Tension-type Headache (TTH) on Quality of Life Time Frame: 1 year	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.	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

Study Chair: Dalia Mahran, prof, assiut
Study Chair: Ghaydaa Shehata, prof, assiut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 10, 2026

Primary Completion (Estimated)

November 10, 2027

Study Completion (Estimated)

August 10, 2028

Study Registration Dates

First Submitted

August 11, 2026

First Submitted That Met QC Criteria

August 18, 2026

First Posted (Actual)

August 21, 2026

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria