Sleep HygieneNCT05193136
Sleep Hygiene, Sarcopenia, and Cognitive Function in Respiratory Disease
An observational study of Sleep Hygiene and Sarcopenia, run by National Hospital Organization Minami Kyoto Hospital at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sleep Hygiene, Sarcopenia, Cognitive Function
- How many people
- 120 participants
- Where
- 1 siteJapan
- Study dates
- 10 Dec 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD or IPF
Who may be able to join
- Subjects with COPD or IPF.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
National Hospital Organization Minami Kyoto Hospital
Jōyō, Kyoto, 610-0113
Yuichi Chihara, MD., PhD., 81-774-52-0065, yc.r03107@gmail.com
About this study
Official title: Examination of the Relationship Between Sleep Hygiene, Sarcopenia, and Cognitive Function in Patients With Chronic Obstructive Pulmonary Disease or Idiopathic Pulmonary Fibrosis
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.
Read the 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.
- Conditions
- Sleep Hygiene, Sarcopenia, Cognitive Function, COPD, IPF
- Medical subject headings
- Sleep Hygiene, Sarcopenia, Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between sleep time at study enrollment and onset of sarcopenia during follow-up period
Measured: Two years
Secondary outcomes (6)
Relationship between sleep time at study enrollment and the onset of mild cognitive impairment during follow-up period
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Two years
Factors associated with the onset of sarcopenia and mild cognitive impairment during follow-up period
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start10 Dec 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Hospital Organization Minami Kyoto Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193136
- Sponsor's protocol ID
- 2020-32
- Status last verified
- Mar 2023
- First submitted
- 31 Dec 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Relationship Between Sleep Hygiene, Sarcopenia, and Cognitive Function in Patients With Chronic Obstructive Pulmonary Disease or Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT05193136
- Acronym / sponsor ID
- 2020-32
- Conditions
- Sleep Hygiene, Sarcopenia, Cognitive Function, COPD, IPF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Hospital Organization Minami Kyoto HospitalUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD or IPF
Key inclusion criteria (1 listed)
- Subjects with COPD or IPF.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between sleep time at study enrollment and onset of sarcopenia during follow-up period
Time frame: Two years
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Hygiene and Sarcopenia, run by National Hospital Organization Minami Kyoto Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between sleep time at study enrollment and onset of sarcopenia during follow-up period (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.