Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05719233

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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 attributed it to reduced oxygenation of the brain. Early detection and accurate management of comorbidity have benefits in reducing ILD morbidity and mortality.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases, Interstitial

Detailed Description

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

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Cognitive impairment [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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