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NCT Number: NCT07503171

Hypoxia and Hemodilution Testing in Healthy Adult Volunteers

This study will collect physiological measurements in healthy adult volunteers under controlled hypoxia and hemodilution conditions.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Subjects will undergo stepwise reductions in oxygen saturation and hemoglobin concentration while noninvasive monitoring data are recorded and compared with reference blood measurements.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • In good general health with no evidence of significant medical problems.
  • Fluent in both written and spoken English.
  • Has provided written informed consent and is willing to comply with study procedures.

Exclusion criteria

  • BMI above 30.
  • History of heart, lung, kidney, or liver disease.
  • Diagnosis of asthma, sleep apnea, or use of CPAP.
  • Diabetes mellitus.
  • Clotting disorders.
  • Hemoglobinopathy or history of anemia (ctHb <12 g/dL for men, <11 g/dL for women, COHb >2%).
  • Any serious systemic illness.
  • Current smoker.
  • Injury or abnormality at sensor sites interfering with measurements.
  • History of fainting or vasovagal response.
  • Sensitivity to local anesthesia.
  • Diagnosis of Raynaud's disease.
  • Unacceptable collateral circulation (Allen's test).
  • Pregnant, lactating, or attempting to become pregnant.
  • Unable or unwilling to provide informed consent or comply with study procedures.
  • Any other condition deemed unsuitable by the investigator.

Treatment and study plan

Noninvasive Physiological Monitoring Device

Device

Octopal R Noninvasive Pulse Wave Measuring Device DMO-8000X with TL 811S Finger Probe

Primary outcomes

  1. Collection of Hemoglobin and Oxygen Saturation Measurements

    Time frame: From enrollment to the end of treatment up to 8 hours

    Collect device readings of oxygen saturation and hemoglobin concentration and reference values obtained from arterial blood samples analyzed using a multi-wavelength laboratory oximeter.

Study contacts

Contact information is provided by the study sponsor or research team.

Greg Stratmann, MD, PhD

CONTACT

[email protected]

(650) 868-5155

Steve Weisner, MS

CONTACT

[email protected]

617-318-5904

Sponsors and collaborators

Lead sponsor

Nihon Kohden

Industry

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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