Sleep Hygiene, Sarcopenia, and Cognitive Function in Respiratory Disease

NCT ID: NCT05193136

Last Updated: 2023-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-10

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep Hygiene Sarcopenia Cognitive Function COPD IPF

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Hospital Organization Minami Kyoto Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Hospital Organization Minami Kyoto Hospital

Jōyō, Kyoto, Japan

Site Status RECRUITING

Countries

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Japan

Facility Contacts

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Yuichi Chihara, MD., PhD.

Role: primary

81-774-52-0065

Other Identifiers

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2020-32

Identifier Type: -

Identifier Source: org_study_id

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