Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases, Interstitial

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Interstitial lung disease patients diagnosed using high resolution computed tomography to confirm the diagnosis

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	1 MONTH

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Waleed Gamal Elddin Khaleel, Lecturer, Assiut university, Egypt

Publications and helpful links

General 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.
• Ryu 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.
• Bors 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cognitive function; anxiety; spirometry; Interstitial lung disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: Neuropsychiatric Sequel of ILD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No