رادار التجارب السريرية

Belun Ring Oxygen Saturation

Oximeter with pulse rate registration. The oximeter will provide the average level of oxygen saturation in the blood, provided in a percentage outcome. .

baseline and then monthly for 3 months.

Belun Ring lowest Oxygen Saturation Level

Oximeter with pulse rate registration. The oximeter will provide the lowest level of oxygen saturation recorded as a percentage.

baseline and then monthly for 3 months.

Belun Ring Oxygen Saturation under 70%

Oximeter with pulse rate registration. The oximeter will provide the percentage of sleep that was under 70% SpO2.

baseline and then monthly for 3 months.

Belun Ring AHI

Oximeter with pulse rate registration. The oximeter provides the Apnea/Hypopnea Index which is the number of apneic events per hour of sleep.

baseline and then monthly for 3 months.

Belun Ring Pulse Rate

Oximeter with pulse rate registration. The oximeter provides the pulse rate as the average beats per minute with standard deviation, and range.

baseline and then monthly for 3 months.

SnoreLab app

A mobile phone app that records snoring when present, and categorizes into amount and level. Possible outcomes are: none, mild, moderate, severe, and epic.

baseline and monthly for 3 months.

Tongue Elevation strength

The Iowa Oral Performance Instrument, is a validated intraoral device that measures tongue elevation strength in kPa.

baseline and monthly for 3 months.

Tongue Protrusion strength

The Iowa Oral Performance Instrument is a validated intraoral device that measures tongue protrusion strength in kPa.

baseline and monthly for 3 months.

Buccinator strength

The Iowa Oral Performance Instrument is a validated intraoral device that measure the buccinator muscle strength in kPa.

baseline and monthly for 3 months.

STOP-Bang Questionnaire

STOP-Bang is a validated tool that determines if the subject is at no, low, moderate, or severe risk of sleep-apnea. It provides an objective score that ranges from 0 to 8.

baseline and monthly for 3 months.

Nasal Obstruction Assessment (NOSE) Questionnaire Score

NOSE is a validated tool that determines the level of difficulty that the subject experienced in breathing through their nose in the past 3 months. The questionnaire provides an objective score stating the risk level that ranges from 0 to 100 with lower scores indicating less nasal blockage and higher scores indicating worse nasal blockage.

baseline and monthly for 3 months.

PROMIS Sleep Disturbance 8b Short Form Questionnaire

Assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. Each question usually has five response options ranging in value from one to five. Values are summed to generate a raw score that is then translated to a t-score with a mean of 50, std of 10.

baseline and monthly for 3 months.

Epworth Daytime Sleepiness Questionnaire

This is a validated tool that measures a person's daytime sleepiness and is commonly used to help diagnose sleep disorders. Eight prompts with each response scored from 0-3. Higher scores indicates greater sleepiness. It provides an objective score that can range from 0 to 24.

baseline and monthly for 3 months.

PROMIS Sleep Impairment 8a Short Form Questionnaire

Assesses self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Each question usually has five response options ranging in value from one to five. Values are summed to generate a raw score which is then translated to a t-score with a mean of 50, std of 10.

baseline and monthly for 3 months.