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The Screening and the Treatment of ECG Holter and Sleep Apnea

Primary Purpose

The Screening and the Treatment of ECG Holter and Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
CPAP
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for The Screening and the Treatment of ECG Holter and Sleep Apnea focused on measuring sleep healthcare, actigraph devices, questionnaires, ECG Holter

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: age:≧20 year-old Mild Obstructive Sleep Apnea (AHI≥5-15/hr)(30 patients) Moderate Obstructive Sleep Apnea (AHI≥15-30/hr) (80 patients) Severe Obstructive Sleep Apnea (AHI≥30/hr)(80 patients) Exclusion Criteria: skin allergy wrist tattoos BMI≧40 kg/m2 Neurological Disorders(Infection, Stroke, ALS, Myopathy, Brain tumor and Encephalitis) Internal Diseases(cardiovascular disease or coronary artery disease was poorly controlled chronic heart failure(including NYHA class 3 or more than NYHA class 3) COPD(FEV1/FVC<70) Hyperthyroidism or Hypothyroidism Primary Aldosteronism Chronic Kidney Disease(eGFR<30) Acromegaly and Parkinson's disease) Psychosis(Schizophrenia, bipolar disorder and depression) Autoimmune disease(System Lupus Erythematosus, Rheumatoid arthritis, Sarcoidosis, Crohn's disease and Ulcerative Colitis) Cancer(in last 5 years) Have been diagnosed with obstructive sleep apnea other sleep disorder(Narcolepsy, insomnia and RBD) Use anti-inflammatory drugs(in last 2 weeks) Illiterate shift worker has been Spinal Surgery and move difficult professional driver has severe drowsiness

Sites / Locations

  • Center of sleep disorders, National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cpap

Usual care

Arm Description

usage cpap 3 months

Usual care 3smonths

Outcomes

Primary Outcome Measures

Questionnaires from OSA population
Primary outcome

Secondary Outcome Measures

Full Information

First Posted
June 25, 2023
Last Updated
July 3, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05928923
Brief Title
The Screening and the Treatment of ECG Holter and Sleep Apnea
Official Title
The Screening and the Treatment of ECG Holter and Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Sleep quality affect working and learning performance; poor quality of sleep is one of the common problems of modern people. Traditionally, polysomnography is a recognized standard for sleep quality assessment. Subjects are put adhesive electrodes, chest and abdomen band, oximetery, and oronasal cannula and stay in certified sleep laboratory for monitoring. These sensors setup are cumbersome and be likely to induce discomfort. An alternative to assess the quality of sleep is actigraphy, which allows users to wear for more than two weeks. In recent years, many of the devices, which often measure physiological signals, are prevailing to make long-term sleep monitoring feasible, but its accuracy and effectiveness still need to be verified. Obstructive sleep apnea (OSA) is a common disorder characterized by intermittent hypoxia and sleep fragmentation. OSA is associated with cardiovascular morbidity and mortality, metabolic dysregulation, and neurocognitive dysfunction, which results in the negative impact on prognosis. PSG is the gold standard for OSA diagnosis which is expensive and less accessible. Therefore, modality other than PSG is necessary to speed up diagnosis and treatment. Center of Sleep Disorder in National Taiwan University Hospital has been operated since June 2006. Up to Dec.2015, totally 8,819 patients have been referred for sleep studies (NTUH cohort) where 1,435 patients are under long-term CPAP and 396 patients are under MAD. Using data from 4,618 patients in NTUH cohort, we have already established an OSA prediction mode (apnea-hypopnea index, AHI≥5/hr) with accuracy 82.37% (sensitivity 87.03%, positive predictive value 91%). Regarding the molecular mechanism, our previous study showed that by plasma metabolomics profiling, we could identify candidate metabolites associated with OSA severity. The 11 candidate metabolites were identified by comparing profiling in 100 patients with AHI <15/hr and with AHI≥ 15/hr, respectively. Six identified metabolites were selected to establish an AHI prediction model which gave sensitivity 66%, specificity 72%, and AUROC 0.736. Furthermore, 15 plasma metabolites associated with excessive daytime sleepiness (EDS) or polysomnographic parameters were identified. Among those metabolites, L-Kynurenine and g-Glutamylleucine were metabolites associated with EDS which generated the AUROC to EDS prediction as 63% in study group and 76.7% in validation group. The "LARGAN"ECG Holter for diagnosis of sleep disorder has been set up by LARGAN-health. It aims on population with simple diagnosis of sleep disorder. Combining the "LARGAN"ECG Holter provides the diagnosis and solution of sleep disorder, sleep tracking, and education. This devices is almost set and needs the input from general population to validate the accuracy. The trial, which includes questionnaires, Actigraph devices, 24-hr BP and "LARGAN"ECG Holter for long-term home sleep monitoring, is proposed to allow users to detect potential subjects who have sleep disorders by using the ECG Holter. The aims of the present project include: (1) All 190 voluntary. Recruit 30 voluntary participants from patients with mild OSA (AHI≥5-15/hr), 160 for each voluntary participants from patients with moderate OSA (AHI≥15-30/hr) and severe OSA (AHI≥30/hr) to validate agreement of sleep efficiency via this trial, Actigraph devices and ECG Holter for 9 days, and 24 hour blood pressure for one day. (2) All participants will take an overnight PSG test, blood sampling, basal metabolism measurement, Actigraph devices, ECG Holter, body composition and E-Prime at the sleep center to validate the performance of this system on diagnosis of OSA in low risk population. (3) Analyze the of PSG parameters in both low and high risk population (to build up the out of center devices for OSA home testing). (4) Integrate the clinical parameters and plasma metabolic profile, before and after treatment, to identify factors associated with OSA related sequels and long-term prognosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Screening and the Treatment of ECG Holter and Sleep Apnea
Keywords
sleep healthcare, actigraph devices, questionnaires, ECG Holter

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cpap
Arm Type
Experimental
Arm Description
usage cpap 3 months
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care 3smonths
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
CPAP usage 3 months
Primary Outcome Measure Information:
Title
Questionnaires from OSA population
Description
Primary outcome
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age:≧20 year-old Mild Obstructive Sleep Apnea (AHI≥5-15/hr)(30 patients) Moderate Obstructive Sleep Apnea (AHI≥15-30/hr) (80 patients) Severe Obstructive Sleep Apnea (AHI≥30/hr)(80 patients) Exclusion Criteria: skin allergy wrist tattoos BMI≧40 kg/m2 Neurological Disorders(Infection, Stroke, ALS, Myopathy, Brain tumor and Encephalitis) Internal Diseases(cardiovascular disease or coronary artery disease was poorly controlled chronic heart failure(including NYHA class 3 or more than NYHA class 3) COPD(FEV1/FVC<70) Hyperthyroidism or Hypothyroidism Primary Aldosteronism Chronic Kidney Disease(eGFR<30) Acromegaly and Parkinson's disease) Psychosis(Schizophrenia, bipolar disorder and depression) Autoimmune disease(System Lupus Erythematosus, Rheumatoid arthritis, Sarcoidosis, Crohn's disease and Ulcerative Colitis) Cancer(in last 5 years) Have been diagnosed with obstructive sleep apnea other sleep disorder(Narcolepsy, insomnia and RBD) Use anti-inflammatory drugs(in last 2 weeks) Illiterate shift worker has been Spinal Surgery and move difficult professional driver has severe drowsiness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Lin Lee, M.D., PhD
Phone
+886-223562755
Email
leepeilin@ntu.edu.tw
Facility Information:
Facility Name
Center of sleep disorders, National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peilin Lee
Email
leepeilin@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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The Screening and the Treatment of ECG Holter and Sleep Apnea

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