Sleep Hygiene, Sarcopenia, and Cognitive Function in Respiratory Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sleep Hygiene, Sarcopenia, Cognitive Function, COPD. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Examination of the Relationship Between Sleep Hygiene, Sarcopenia, and Cognitive Function in Patients With Chronic Obstructive Pulmonary Disease or Idiopathic Pulmonary Fibrosis
Overview
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.
Primary outcome measures
- Relationship between sleep time at study enrollment and onset of sarcopenia during follow-up period [Time frame: Two years]
Secondary outcome measures (6)
- Relationship between sleep time at study enrollment and the onset of mild cognitive impairment during follow-up period [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Two years]
- Factors associated with the onset of sarcopenia and mild cognitive impairment during follow-up period [Time frame: Two years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Japan · 1 center
- National Hospital Organization Minami Kyoto Hospital — Jōyō
Identifiers
NCT: NCT05193136 · 2020-32