Sleep Hygiene, Sarcopenia, and Cognitive Function in Respiratory Disease

NCT05193136 | Recruiting

• 1 other identifier: 2020-32
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Hygiene; Sarcopenia; Cognitive Function; COPD; IPF

Outcome Measures

Primary Outcomes (1)

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

  Two years

Secondary Outcomes (6)

• 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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD or IPF

You may qualify if:

• Subjects with COPD or IPF.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Hospital Organization Minami Kyoto Hospital: lead

Study Sites (1)

National Hospital Organization Minami Kyoto Hospital

Jōyō, Kyoto, 610-0113, Japan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (serum, plasma)

MeSH Terms

Conditions

Sleep Hygiene; Sarcopenia; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 14, 2022
• Study Start: December 10, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

JP (1)