Belun Ring Validation Study for Assessment of Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

A Validation Investigation of the Accuracy of the Belun Ring, an Innovative Single-channel Four-signal Pulse Oximetry, in Patients Referred to Sleep Lab for Assessment of Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03997916
• Other study ID #: STUDY20181042
• Status: Completed
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: July 30, 2019

Study information

• Verified date: April 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to determine the overall accuracy, sensitivity, and specificity of the Belun Ring device in evaluating obstructive sleep apnea by comparing the device to the attended overnight in-lab polysomnography which is the gold standard for diagnosis of obstructive sleep apnea. Our hypothesis is that the Belun-Ring, a type 4 portable monitoring device, is overall sensitive and specific for evaluation of obstructive sleep apnea when compared to the attended overnight in-lab polysomnography.

Description:

This study will include all patients who are scheduled to do an attended overnight in-lab polysomnography in 2 sleep labs owned by University Hospitals Cleveland Medical Center. These patients will receive email recruitment forms 2 weeks prior their scheduled polysomnography. Whether they are interested or not, patients are supposed to call or email the study's central contact person. Both phone number and email address of the central contact person are noted in the email recruitment form. For those patients who did not make any contact with the study's central contact person, they will be screened for eligibility by sub-investigators through chart review. List of eligible patients will be sent to the central contact backup person who is basically in-charge of making phone calls to the patients. This person will further confirm patients' eligibility over the phone and ask if they are interested. If a patient is interested, the central contact backup person will inform the sub-investigators who, in turn, will assign a unique patient identifier to the interested subject and inform the sleep lab contact person. The sleep lab contact person will, in turn, inform the sleep technicians on-call ahead of time about the list of interested subjects. On the night of the polysomnography testing of the interested subject, the latter will receive questionnaires and written informed consent form related to the study which will be explained by the sleep technician. After the subject had completed and signed the questionnaires and written informed consent form respectively, the sleep technician will apply the Belun Ring device on the patient as well as the electrodes and sensors included in a routine polysomnography. The following day, data from Belun Ring device will be uploaded to the laptop while another sleep technician will read the polysomnography. Sub-investigators will enter the data from the questionnaires, Belun Ring device, and polysomnography in the secured University Hospitals Redcap (UHRedcap). Once the target number of subjects are reached, all data will be sent to statistician for analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: July 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All adult patients age 18-80 years old scheduled for overnight in-lab sleep study

• Provision of signed and dated written informed consent form

Exclusion Criteria:

• Recent hospitalization in the past 30 days

• Patients on home oxygen, non-invasive ventilator, diaphragmatic pacing, or any form of nerve stimulator

• Patients with pacemaker, defibrillator, left ventricular assist device (LVAD), or status post cardiac transplantation

• Patients with baseline heart rate under 50 bpm or over 100 bpm during last clinic visit or prior to study at the sleep lab

• Patients with unstable cardiopulmonary status judged to be unsafe for sleep study by the sleep technician and/or the on-call sleep physician in the sleep lab on the night of the study

• Patients who are unable to complete the required study

• Patients involved in another investigational study

• Pregnant women

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Belun Ring
All patients scheduled for attended overnight in-lab polysomnography (PSG) in our 2 sleep labs will undergo PSG testing. On the same night of the PSG testing, these same patients will also wear the Belun Ring device. After the study, we will compare results of the Belun Ring device vis-à-vis with the results of the PSG on the same patient.

Diagnostic Test:
• PSG
All patients scheduled for attended overnight in-lab polysomnography (PSG) in our 2 sleep labs will undergo PSG testing. On the same night of the PSG testing, these same patients will also wear the Belun Ring device. After the study, we will compare results of the Belun Ring device vis-à-vis with the results of the PSG on the same patient.

Locations

Country	Name	City	State
United States	Residence Inn Marriott	Beachwood	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Belun Technology Company Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance (Mean With 95% CI) of bAHI at PSG--AHI Cutoffs of 5, 15 and 30 (Accuracy)	Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea	Same night when both testing were done on the same subject
Primary	Sensitivity	Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea	Same night when both testing were done on the same subject
Primary	Specificity	Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea	Same night when both testing were done on the same subject