Sleep Hygiene, Sarcopenia, and Cognitive Function in Respiratory Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia; Cognitive Function; COPD; Sleep Hygiene; IPF

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Japan
  • Kyoto
    • Joyo, Kyoto, Japan, 610-0113
      • Recruiting
      • National Hospital Organization Minami Kyoto Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD or IPF

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relationship between sleep time at study enrollment and onset of sarcopenia during follow-up period	Two years

Secondary Outcome Measures

Outcome Measure	Time Frame
Relationship between sleep time at study enrollment and the onset of mild cognitive impairment during follow-up period	Two years
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
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
Factors associated with the onset of sarcopenia and mild cognitive impairment during follow-up period	Two years

Collaborators and Investigators

• Sponsor: National Hospital Organization Minami Kyoto Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: December 31, 2021
• First Submitted That Met QC Criteria: December 31, 2021
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 2020-32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No