Sleep Hygiene, Sarcopenia, and Cognitive Function in Resp... | NCT05193136

Studies
Sleep Hygiene, Sarcopenia, and Cognitive Function in Respiratory Disease

NCT05193136

Sponsor

National Hospital Organization Minami Kyoto Hospital

Status

Recruiting

Last Update Posted

Mar 28, 2023Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Sleep Hygiene
Sarcopenia
Cognitive Function
COPD
IPF

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2021Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Dec 31, 2021

First Submission Date that Met QC Criteria

Dec 31, 2021

First Posted Date

Jan 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2023

Last Update Posted Date

Mar 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with COPD or IPF

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Hospital Organization Minami Kyoto Hospital	Recruiting	Jōyō	Kyoto	610-0113	Japan

Condition Browse Module

MeSH Terms

ID	Term
D000070263	Sleep Hygiene
D055948	Sarcopenia
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided