Lung Diseases, InterstitialNCT05719233
Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease
An observational study of Lung Diseases, Interstitial, run by Assiut University at 1 site in Egypt.
Trial summary
Research on the impact of lung diseases on neuropsychological functioning has revealed impaired cognitive processing in patients with a variety of pulmonary disorders. While the mechanisms responsible for the association of pulmonary diseases and neurocognitive functioning remain unclear, some researchers have… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases, Interstitial
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Dec 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Interstitial lung disease patients diagnosed using high resolution computed tomography to confirm the diagnosis either visiting out patient clinic or admitted to ward in assiut university hospital.
Who may be able to join
- Interstitial lung disease patients diagnosed using high resolution computed tomography to confirm the diagnosis
Who cannot join
- Patients who refuse to participate in the study.
- Age less than 18,
- A history of neurological and/or developmental disorders and related drug treatment,
- A head injury with loss of consciousness,
- Active alcohol or drug abuse or a history of abuse prior to testing,
- A history of any psychiatric disorder or treatment, neurological disorders, psychological disorders, dementia, Alzheimer's disease, end-organ failure conditions
Trial locations and contacts
1 site in 1 country.
About this study
Research on the impact of lung diseases on neuropsychological functioning has revealed impaired cognitive processing in patients with a variety of pulmonary disorders. While the mechanisms responsible for the association of pulmonary diseases and neurocognitive functioning remain unclear, some researchers have attributed it to reduced oxygenation of the brain. Early detection and accurate management of comorbidity have benefits in reducing ILD morbidity and mortality.
Read the detailed description
Research on the impact of lung diseases on neuropsychological functioning has revealed impaired cognitive processing in patients with a variety of pulmonary disorders. While the mechanisms responsible for the association of pulmonary diseases and neurocognitive functioning remain unclear, some researchers have attributed it to reduced oxygenation of the brain.
Interstitial Lung Disease (ILD) is an "umbrella" term as it comprises a variety of pulmonary diseases which affect the interstitium (the tissue and space around the air sacs of the lungs). It may be caused by a variety of factors (namely, inhaled substances, medications, infection, connective tissue disease, malignancy or idiopathic reasons) and has a clear negative impact on patients' quality of life, leading to symptoms such as fatigue, dyspnea and coughing. Physical sequelae include reduced lung volumes due to tissue thickening, sometimes caused by inflammation. A further consequence is reduced breathing efficiency, resulting in reduced blood oxygen levels and compromised exercise capacity.
Additionally, the fibrosis of the parenchyma impedes the level of gas exchange. A number of studies have reported mood effects in ILD, suggesting, however, that the diagnosis of depression may be obscured, due to the fatigue and apathy that is often a consequence of ILD.
Early detection and accurate management of Neuropsychiatric comorbidities have benefits in reducing ILD morbidity and mortality.
- Conditions
- Lung Diseases, Interstitial
- Keywords
- Interstitial lung disease, cognitive function, spirometry, anxiety
- Medical subject headings
- Lung Diseases, Interstitial, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Interstitial Lung disease Group | Mini-mental state examination (MMSE) Hamilton Anxiety Rating Scale Hamilton Depression Rating Scale Nerve conduction studies High resolution Chest Computed tomography Pulmonary function Test | |
| Control Group | Mini-mental state examination (MMSE) Hamilton Anxiety Rating Scale Hamilton Depression Rating Scale Nerve conduction studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive impairment
a 30-point test used to assess cognitive function; includes tests of orientation, attention, memory, language, and visual-spatial skills. MMSE score 24-30: no cognitive impairment, 19-23: mild cognitive impairment, 10-18: moderate cognitive impairment, ≤ 9: severe cognitive impairment
Measured: 1 MONTH
Anxiety level
consists of 14 items and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where a score ≤ 17 indicates mild anxiety, 18-24 mild to moderate severity, and more than 24 moderate to severe anxiety
Measured: 1 MONTH
Depression level
The original HAM-D has 21 items, but scoring is based only on the first 17. Scores less than or equal to 7 indicates normal response, 8-13 mild depression, 14-18 Moderate, 19-22 severe, and more than 22 very severe depression
Measured: 1 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Oct 2022
- Primary completion1 Sep 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung Diseases, InterstitialStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Gamal Elddin Khaleel, Assiut University
- Investigators
- Waleed Gamal Elddin Khaleel, Lecturer, Principal investigator, Assiut university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719233
- Sponsor's protocol ID
- Neuropsychiatric Sequel of ILD
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antonelli-Incalzi R, Corsonello A, Trojano L, Acanfora D, Spada A, Izzo O, Rengo F. Correlation between cognitive impairment and dependence in hypoxemic COPD. J Clin Exp Neuropsychol. 2008 Feb;30(2):141-50. doi: 10.1080/13803390701287390.
PubMed 18938666Ryu JH, Daniels CE, Hartman TE, Yi ES. Diagnosis of interstitial lung diseases. Mayo Clin Proc. 2007 Aug;82(8):976-86. doi: 10.4065/82.8.976.
PubMed 17673067Bors M, Tomic R, Perlman DM, Kim HJ, Whelan TP. Cognitive function in idiopathic pulmonary fibrosis. Chron Respir Dis. 2015 Nov;12(4):365-72. doi: 10.1177/1479972315603552. Epub 2015 Sep 15.
PubMed 26374298
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT05719233
- Acronym / sponsor ID
- Neuropsychiatric Sequel of ILD
- Conditions
- Lung Diseases, Interstitial
- Keywords
- Interstitial lung disease, cognitive function, spirometry, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 8 Feb 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.
Research on the impact of lung diseases on neuropsychological functioning has revealed impaired cognitive processing in patients with a variety of pulmonary disorders. While the mechanisms responsible for the association of pulmonary diseases and neurocognitive functioning remain unclear, some researchers have attributed it to reduced oxygenation of the brain. Early detection and accurate management of comorbidity have benefits in reducing ILD morbidity and mortality.
Detailed description
Research on the impact of lung diseases on neuropsychological functioning has revealed impaired cognitive processing in patients with a variety of pulmonary disorders. While the mechanisms responsible for the association of pulmonary diseases and neurocognitive functioning remain unclear, some researchers have attributed it to reduced oxygenation of the brain.
Interstitial Lung Disease (ILD) is an "umbrella" term as it comprises a variety of pulmonary diseases which affect the interstitium (the tissue and space around the air sacs of the lungs). It may be caused by a variety of factors (namely, inhaled substances, medications, infection, connective tissue disease, malignancy or idiopathic reasons) and has a clear negative impact on patients' quality of life, leading to symptoms such as fatigue, dyspnea and coughing. Physical sequelae include reduced lung volumes due to tissue thickening, sometimes caused by inflammation. A further consequence is reduced breathing efficiency, resulting in reduced blood oxygen levels and compromised exercise capacity.
Additionally, the fibrosis of the parenchyma impedes the level of gas exchange. A number of studies have reported mood effects in ILD, suggesting, however, that the diagnosis of depression may be obscured, due to the fatigue and apathy that is often a consequence of ILD.
Early detection and accurate management of Neuropsychiatric comorbidities have benefits in reducing ILD morbidity and mortality.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interstitial Lung disease Group | – | –Mini-mental state examination (MMSE) Hamilton Anxiety Rating Scale Hamilton Depression Rating Scale Nerve conduction studies High resolution Chest Computed tomography Pulmonary function Test |
| Control Group | – | –Mini-mental state examination (MMSE) Hamilton Anxiety Rating Scale Hamilton Depression Rating Scale Nerve conduction studies |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Interstitial lung disease patients diagnosed using high resolution computed tomography to confirm the diagnosis either visiting out patient clinic or admitted to ward in assiut university hospital.
Key inclusion criteria (1 listed)
- Interstitial lung disease patients diagnosed using high resolution computed tomography to confirm the diagnosis
Key exclusion criteria (6 listed)
- Patients who refuse to participate in the study.
- Age less than 18,
- A history of neurological and/or developmental disorders and related drug treatment,
- A head injury with loss of consciousness,
- Active alcohol or drug abuse or a history of abuse prior to testing,
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
Cognitive impairment
Time frame: 1 MONTH
a 30-point test used to assess cognitive function; includes tests of orientation, attention, memory, language, and visual-spatial skills. MMSE score 24-30: no cognitive impairment, 19-23: mild cognitive impairment, 10-18: moderate cognitive impairment, ≤ 9: severe cognitive impairment
Anxiety level
Time frame: 1 MONTH
consists of 14 items and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where a score ≤ 17 indicates mild anxiety, 18-24 mild to moderate severity, and more than 24 moderate to severe anxiety
Depression level
Time frame: 1 MONTH
The original HAM-D has 21 items, but scoring is based only on the first 17. Scores less than or equal to 7 indicates normal response, 8-13 mild depression, 14-18 Moderate, 19-22 severe, and more than 22 very severe depression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Background: PubMed 18938666Antonelli-Incalzi R, Corsonello A, Trojano L, Acanfora D, Spada A, Izzo O, Rengo F. Correlation between cognitive impairment and dependence in hypoxemic COPD. J Clin Exp Neuropsychol. 2008 Feb;30(2):141-50. doi: 10.1080/13803390701287390.
- Background: PubMed 17673067Ryu JH, Daniels CE, Hartman TE, Yi ES. Diagnosis of interstitial lung diseases. Mayo Clin Proc. 2007 Aug;82(8):976-86. doi: 10.4065/82.8.976.
- Background: PubMed 26374298Bors M, Tomic R, Perlman DM, Kim HJ, Whelan TP. Cognitive function in idiopathic pulmonary fibrosis. Chron Respir Dis. 2015 Nov;12(4):365-72. doi: 10.1177/1479972315603552. Epub 2015 Sep 15.
- Individual participant dataSharing planned: No
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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.
Waleed Gamal Elddin Khaleel, Lecturer principal investigator
Assiut university, Egypt
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 Lung Diseases, Interstitial, run by Assiut University 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 12 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive impairment (time frame: 1 MONTH). 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?
On the ClinicalTrials.gov record for NCT05719233, which also lists 3 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 12 Jan 2024.