Clinical trial NCT03710993: Accuracy Assessment of Beddr Oximeter
Official title: Beddr Sleep SpO2 Equivalency Calibration Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oximetry
Lead sponsor: Hancock Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adult volunteers, ranging in pigmentation from light to dark.

Brief summary: Accuracy performance of Beddr oximeter

Detailed description: This study will evaluate the accuracy of the Beddr sleepTuner oximeter compared to a transfer standard and multiple reference devices.

Eligibility criteria: Inclusion Criteria:

* Subject must have the ability to understand and provide written informed consent
* Adult subjects 18 up to 50 years of age
* Subject must be willing and able to comply with study procedures and duration
* Subject is a non-smoker or who has not smoked within 2 days prior to the study.
* Male or female of any race
* Subject demographics include a range of skin pigmentations, including at least 1 darkly pigmented subjects or 15% of the subject pool, whichever is larger.

Exclusion Criteria:

* Subject is considered as being morbidly obese (defined as BMI \>39.5)
* Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
* Females who are pregnant, who are trying to get pregnant or who have a urine test positive for pregnancy on the day of the study
* Subjects with known respiratory conditions such as:

  * uncontrolled / severe asthma,
  * flu,
  * pneumonia / bronchitis,
  * shortness of breath / respiratory distress,
  * unresolved respiratory or lung surgery with continued indications of health issues,
  * emphysema, COPD, lung disease
* Subjects with known heart or cardiovascular conditions such as:

  * Hypertension: systolic \>140mmHg, Diastolic \>90mmHg on 3 consecutive readings.
  * have had cardiovascular surgery
  * Chest pain (angina)
  * heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
  * previous heart attack
  * blocked artery
  * unexplained shortness of breath
  * congestive heart failure (CHF)
  * history of stroke
  * transient ischemic attack
  * carotid artery disease
  * myocardial ischemia
  * myocardial infarction
  * cardiomyopathy
* Self-reported health conditions as identified in the Health Assessment Form

  * diabetes,
  * uncontrolled thyroid disease,
  * kidney disease / chronic renal impairment,
  * history of seizures (except childhood febrile seizures),
  * epilepsy,
  * history of unexplained syncope,
  * recent history of frequent migraine headaches,
  * recent head injury within the last 2 months,
  * cancer / chemotherapy
* Subjects with known clotting disorders

  * history of bleeding disorders or personal history of prolonged bleeding from injury
  * history of blood clots
  * hemophilia
  * current use of blood thinner: prescription or daily use of aspirin
* Subjects with Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors
* Unwillingness or inability to remove colored nail polish or non-clear artificial nails from test digits.
* Other known health condition, should be considered upon disclosure in health assessment form

Primary outcomes:
measure: SpO2 accuracy
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Clinimark
state: Colorado
Study officials:
affiliation: Clinimark, LLC
name: Arthur Cabrera, MD
role: PRINCIPAL_INVESTIGATOR
References: