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Completed

NCT Number: NCT05719233

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut university hospitals

Asyut, 71515, Egypt

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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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