Sleep Hygiene, Sarcopenia, and Cognitive Function in Respiratory Disease

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05193136
• Other study ID #: 2020-32
• Status: Recruiting
• Start date: December 10, 2021
• Est. completion date: December 2027

Study information

• Verified date: March 2023
• Source: National Hospital Organization Minami Kyoto Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Function
• COPD
• IPF
• Sarcopenia
• Sleep Hygiene

Locations

Country	Name	City	State
Japan	National Hospital Organization Minami Kyoto Hospital	Joyo	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
National Hospital Organization Minami Kyoto Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between sleep time at study enrollment and onset of sarcopenia during follow-up period		Two years
Secondary	Relationship between sleep time at study enrollment and the onset of mild cognitive impairment during follow-up period		Two years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Factors associated with the onset of sarcopenia and mild cognitive impairment during follow-up period		Two years