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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05193136

Enrollment

120

Registered

2022-01-14

Start date

2021-12-10

Completion date

2027-12-31

Last updated

2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Function, COPD, IPF, Sarcopenia, Sleep Hygiene

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 at study enrollment and the onset of mild cognitive impairment 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
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

Countries

Japan

Outcome results