Belun Ring Validation Study for Assessment of Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Belun Ring; PSG
Intervention type(s): Device; Diagnostic Test
Intervention description(s): 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.; 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Belun Ring; pulse oximeter; obstructive sleep apnea