OSANCT06058052
Prevalence of OSA in Patients of ILD
An observational study of OSA, run by Assiut University.
Trial summary
To evaluate the clinical predictors of OSA in patients with ILD Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- OSA
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2023to 25 Dec 2024
- How long will I take part?
- 12 Months
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to Assiut University Hospital diagnosed as interstitial lung disease risky for OSA will be included from June 2023 to January 2024.
Who may be able to join
- Patients presented to Chest Department with interstitial lung disease will be included, screened for OSA.
Who cannot join
- Age: less than 18 years. Unstable patients or need for ICU admission
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pattern Of Association Between Obstructive Seep Apnea and Interstitial Lung Disease
To evaluate the clinical predictors of OSA in patients with ILD
Read the detailed description
Interstitial lung diseases (ILDs) are a group of heterogeneous disorders characterized by varying degrees of fibrosis and inflammation of lung parenchyma.
Obstructive sleep apnea is a type of sleep disordered breathing characterized by repeated episodes of apnea and hypopnea during sleep due to narrowing or occlusion of the upper airway.
It was found that the prevalence of OSA is as high as 80% among patients with idiopathic pulmonary fibrosis (IPF). Despite this common association, there is limited research in this field. There is great need for further studies to highlight this association and understand the underlying pathophysiological mechanisms implicated in those patients, to ultimately guide the appropriate management.
- Conditions
- OSA
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of OSA in patients with ILD
By clinical history ,examination, BMI
Measured: Baseline
Secondary outcomes (1)
Prevalence of OSA among patients with ILD Presented To Chest Department in Assiut University Hospital
BY Polysomnography
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start20 Oct 2023 (estimated)
- Primary completion28 Sep 2024 (estimated)
- Study completion25 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mohamed Sayed Mohamed, Assiut University
- Investigators
- Mohamed yassen, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058052
- Sponsor's protocol ID
- ILD,OSA
- Status last verified
- Apr 2023
- First submitted
- 22 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern Of Association Between Obstructive Seep Apnea and Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT06058052
- Acronym / sponsor ID
- ILD,OSA
- Conditions
- OSA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 28 Sep 2024 (estimated)
- Study completion
- 25 Dec 2024 (estimated)
- First posted
- 28 Sep 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.
To evaluate the clinical predictors of OSA in patients with ILD
Detailed description
Interstitial lung diseases (ILDs) are a group of heterogeneous disorders characterized by varying degrees of fibrosis and inflammation of lung parenchyma.
Obstructive sleep apnea is a type of sleep disordered breathing characterized by repeated episodes of apnea and hypopnea during sleep due to narrowing or occlusion of the upper airway.
It was found that the prevalence of OSA is as high as 80% among patients with idiopathic pulmonary fibrosis (IPF). Despite this common association, there is limited research in this field. There is great need for further studies to highlight this association and understand the underlying pathophysiological mechanisms implicated in those patients, to ultimately guide the appropriate management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Assiut University Hospital diagnosed as interstitial lung disease risky for OSA will be included from June 2023 to January 2024.
Key inclusion criteria (1 listed)
- Patients presented to Chest Department with interstitial lung disease will be included, screened for OSA.
Key exclusion criteria (1 listed)
- Age: less than 18 years. Unstable patients or need for ICU admission
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
Predictors of OSA in patients with ILD
Time frame: Baseline
By clinical history ,examination, BMI
1 secondary outcome
Prevalence of OSA among patients with ILD Presented To Chest Department in Assiut University Hospital
Time frame: base line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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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.
Mohamed yassen, MD study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of OSA, 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 1 inclusion and 1 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 28 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hend saleh, MD (01098988712, hend.m.saleh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictors of OSA in patients with ILD (time frame: Baseline). 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 28 Sep 2023.