Validation of Sleep Healthcare System

  • STATUS
    Recruiting
  • End date
    May 22, 2022
  • participants needed
    300
  • sponsor
    National Taiwan University Hospital
Updated on 23 January 2021

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 smart watches, which often measure wrist photoplethysmography (PPG) signal and body movement, 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, AHI5/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 online system (Good Sleep) for diagnosis of sleep disorder has been set up under the collaboration between, NTU, NTUH, and MediaTek. It aims on population with low probability of sleep disorder which compliments the NTUH cohort, high probability of sleep disorder. The online system provides the diagnosis and solution of sleep disorder, sleep tracking, and education via both website and App. The system is almost set and needs the input from general population to validate the accuracy.

The sleep healthcare system, which includes questionnaires, smart watches,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 filling out the questionnaire. The aims of the present project include: (1) All 300 voluntary.Stage1, Recruit 140 voluntary participants from MediaTek to validate agreement of sleep efficiency via online system, actigraph devices, smart watches and daily blood pressure for one week.Stage2, Recruit 160 voluntary participants from patients with moderate-severe OSA (AHI15/hr) to validate agreement of sleep efficiency via online system, actigraph devices, smart watches, ECG Holter and 24 hour blood pressure for one day. (2) All participants will take an overnight PSG test, blood sampling, basal metabolism measurement, ECG Holter, body composition and E-Prime at the sleep center to validate the performance of online 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.

Details
Condition Validation of Sleep Healthcare System
Treatment CPAP
Clinical Study IdentifierNCT04252482
SponsorNational Taiwan University Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 20 yrs?
Gender: Male or Female
Do you have Validation of Sleep Healthcare System?
Do you have any of these conditions: Do you have Validation of Sleep Healthcare System??
Stage1:>=20 year-old
Stage2:>=20 year-old 2-1patients with moderate-severe OSA (AHI15/hr)

Exclusion Criteria

Stage1:Have been diagnosed with obstructive sleep apnea
Stage2:Have been diagnosed with obstructive sleep apnea 2-1BMI40 kg/m2 2-2Acute disease 2-3Chronic disease 2-3Systemic inflammatory state 2-4Use anti-inflammatory drugs 2-5shift worker
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