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NCT Number: NCT05193136

Sleep Hygiene, Sarcopenia, and Cognitive Function in Respiratory Disease

We aim to clarify the relationship between sleep hygiene and the onset of sarcopenia or cognitive dysfunction using sleep time, arousal, and sleep quality as indicators in COPD or IPF patients, and clarify the effects of sleep hygiene on disease progression and life prognosis.

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Key information

Conditions

Sleep Hygiene Atrophy Behavior COPD Chronic Disease Cognitive Function Disease Attributes Health Behavior IPF Lung Diseases Lung Diseases, Obstructive Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Sarcopenia Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Hospital Organization Minami Kyoto Hospital

Jōyō, Kyoto, 610-0113, Japan

Location status: Recruiting

Location contact

Yuichi Chihara, MD., PhD.

CONTACT

[email protected]

81-774-52-0065

About this study

Chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) have been reported to be associated with a high rate of sleep-related disorders such as insomnia, sleep-related hypoventilation, and sleep apnea syndrome.Sleep-related disorders cause symptoms such as daytime sleepiness, decreased ADL, and depression, which causes cognitive dysfunction. Both COPD and IPF have been reported to be associated with cognitive dysfunction. Recently, it has been focused on the relationship between sleep-related disorders and sarcopenia. The relationship between sleep hygiene, cognitive dysfunction, and sarcopenia in the patients with COPD or IPF is not well understood.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with COPD or IPF.

Exclusion criteria

  • Subjects who have been hospitalized for exacerbation of respiratory failure within 1 month of study participation
  • Subjects who have already been diagnosed with sarcopenia or cognitive dysfunction
  • Subjects receiving long-term oxygen therapy (LTOT) or non-invasive ventilation therapy (NIV)
  • Subjects with obstructive sleep apnea who are indicated for continuous positive airway pressure (CPAP)
  • Subjects with severe complications such as cardiovascular disease, liver disease, renal disease, malignancy, and neurological disease.

Treatment and study plan

Primary outcomes

  1. Relationship between sleep time at study enrollment and onset of sarcopenia during follow-up period

    Time frame: Two years

Secondary outcomes

  1. Relationship between sleep time at study enrollment and the onset of mild cognitive impairment during follow-up period

    Time frame: Two years

  2. Relationship between sleep efficiency, arousal at the time of study enrollment and the onset of sarcopenia and mild cognitive impairment during the follow-up period

    Time frame: Two years

  3. Association of sleep time, sleep efficiency, arousal at the time of study enrollment and hospitalization and death due to COPD exacerbations or IPF exacerbations during follow-up period

    Time frame: Two years

  4. Relationship between sleep time, sleep efficiency, arousal at the time of study enrollment and changes in grip strength, walking speed, skeletal muscle mass and cognitive function during follow-up period

    Time frame: Two years

  5. Relationship between sleep time, sleep efficiency, arousal at the time of study enrollment and changes in grip strength, walking speed, skeletal muscle mass and cognitive function at the time of study enrollment

    Time frame: Two years

  6. Factors associated with the onset of sarcopenia and mild cognitive impairment during follow-up period

    Time frame: Two years

Sponsors and collaborators

Lead sponsor

National Hospital Organization Minami Kyoto Hospital

Other

Registry information

Official study title

Examination of the Relationship Between Sleep Hygiene, Sarcopenia, and Cognitive Function in Patients With Chronic Obstructive Pulmonary Disease or Idiopathic Pulmonary Fibrosis

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Jan 14, 2022
Registry last updated
Mar 28, 2023

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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