Sleep Hygiene, Sarcopenia, and Cognitive Function in Respiratory Disease

Sponsor
National Hospital Organization Minami Kyoto Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05193136
Collaborator
(none)
120
1
59.7
2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Examination of the Relationship Between Sleep Hygiene, Sarcopenia, and Cognitive Function in Patients With Chronic Obstructive Pulmonary Disease or Idiopathic Pulmonary Fibrosis
    Actual Study Start Date :
    Dec 10, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2026

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Hospital Organization Minami Kyoto Hospital Joyo Kyoto Japan 610-0113

    Sponsors and Collaborators

    • National Hospital Organization Minami Kyoto Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Hospital Organization Minami Kyoto Hospital
    ClinicalTrials.gov Identifier:
    NCT05193136
    Other Study ID Numbers:
    • 2020-32
    First Posted:
    Jan 14, 2022
    Last Update Posted:
    Jan 18, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 18, 2022