Clinical trial NCT05193136: Sleep Hygiene, Sarcopenia, and Cognitive Function in Respiratory Disease
Official title: Examination of the Relationship Between Sleep Hygiene, Sarcopenia, and Cognitive Function in Patients With Chronic Obstructive Pulmonary Disease or Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Hygiene
Sarcopenia
Cognitive Function
COPD
IPF
Lead sponsor: National Hospital Organization Minami Kyoto Hospital
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD or IPF

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.

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.

Primary outcomes:
measure: Relationship between sleep time at study enrollment and onset of sarcopenia during follow-up period
timeFrame: Two years
Secondary outcomes:
measure: Relationship between sleep time at study enrollment and the onset of mild cognitive impairment during follow-up period
timeFrame: Two years
measure: 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
timeFrame: Two years
measure: 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
timeFrame: Two years
measure: 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
timeFrame: Two years
measure: 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
timeFrame: Two years
measure: Factors associated with the onset of sarcopenia and mild cognitive impairment during follow-up period
timeFrame: Two years
Other outcomes:
Locations:
city: Joyo
country: Japan
facility: National Hospital Organization Minami Kyoto Hospital
state: Kyoto
Study officials:
References: