Sleep Hygiene, Sarcopenia, and Cognitive Function in Respiratory Disease

Recruiting

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

• Registration Number: NCT05193136
• Lead Sponsor: National Hospital Organization Minami Kyoto Hospital

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.

Study Timeline

• Study Start: 2021-12-10
• Study First Submitted: 2021-12-31
• Study First Submitted QC: 2021-12-31
• Study First Posted: 2022-01-14
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-25
• Last Update Posted: 2023-03-28
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship between sleep time at study enrollment and onset of sarcopenia during follow-up period	Two years

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

National Hospital Organization Minami Kyoto Hospital; 🇯🇵 Joyo, Kyoto, Japan