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Validation of RespiLife for Detection of Respiratory Suppression

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Bioresp Technologies

Status

Completed

Conditions

Respiration Disorders

Treatments

Diagnostic Test: Respilife monitor

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for detection of respiratory rate and oxygen saturation in human subjects. This includes evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and oxygen saturation.

Full description

The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for detection of respiratory rate and oxygen saturation in human subjects. This includes evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and oxygen saturation.

Enrollment

30 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Able to understand and sign the informed consent
  • English speaking.
  • Able to comply with visits and follow ups included in this protocol
  • Ages 18-80 years

Exclusion criteria

  • Mentally or cognitively incompetent persons who cannot understand the procedures or consent to the procedures.
  • An unstable medical condition, acute of chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection.
  • If a subject is not able to stop his CPAP or BiPAP therapy at least one week prior to the sleep study night. This will be determined ty the principal investigator based on her judgment.
  • Skin rash on the forehead.
  • A history of skin allergy to medical tape, even hypoallergenic tape.
  • A history of skin cancer on the forehead.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Normal subjects
No Intervention group
respiratory suppressing drugs
Active Comparator group
Treatment:
Diagnostic Test: Respilife monitor

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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