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Clinical Trials/NCT05193136
NCT05193136
Recruiting
Not Applicable

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

National Hospital Organization Minami Kyoto Hospital1 site in 1 country120 target enrollmentDecember 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Hygiene
Sponsor
National Hospital Organization Minami Kyoto Hospital
Enrollment
120
Locations
1
Primary Endpoint
Relationship between sleep time at study enrollment and onset of sarcopenia during follow-up period
Status
Recruiting
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 10, 2021
End Date
December 2027
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
National Hospital Organization Minami Kyoto Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: Two years

Secondary Outcomes

  • 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)
  • Factors associated with the onset of sarcopenia and mild cognitive impairment during follow-up period(Two years)
  • Relationship between sleep time at study enrollment and the onset of mild cognitive impairment during follow-up period(Two years)
  • 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)
  • 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)
  • 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)

Study Sites (1)

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