Skip to main content
OpenTrials
Completed

NCT Number: NCT06367686

Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor

The study is an open, prospective, single center clinical observational pilot investigation. The aim is to compare the carbon dioxide values measured by the IscAlert sensor, which is inserted in proximity to the nasal mucosa. The study wants to investigate if the nasal mucosa application and measurements are feasible, what kind of possible complications such a measurement can cause, and if the measurements can be a surrogate marker for systemic carbon dioxide values.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercapnic Respiratory Failure Apnea Chronic Disease Disease Attributes Dyssomnias Hypoventilation Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Neuromuscular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity Hypoventilation Syndrome Obesity Hypoventilation Syndrome (OHS) Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vestfold Hopsital Trust

Tønsberg, 3103, Norway

About this study

he study is an open, prospective, single center clinical observational pilot investigation including 9 patients and 2 healthy volunteers. The aim is to compare the carbon dioxide values measured by the IscAlert sensor, which is inserted in proximity to the nasal mucosa, with the transcutaneous carbon dioxide values measured at the forehead by a transcutaneous carbon dioxide-monitor, the arterial carbon dioxide measurements performed by blood gas analyses, and carbon dioxide measurements registered with the IscAlert sensor implanted in the muscle of the forearm. The study wants to investigate if the nasal mucosa application and measurements are feasible, what kind of possible complications such a measurement can cause, and if the measurements can be a surrogate marker for systemic carbon dioxide values. The study will include patients with a tendency to hypoventilation, thereby giving rise to a carbon dioxide retention; 3 patients with chronic obstructive pulmonary disease with suspected hypercapnic respiratory failure who are evaluated for non-invasive mask-treatment and long-term oxygen treatment supply if needed. 3 patients with neuromuscular disorders and 3 patients with obesity hypoventilation syndrome who are evaluated for non-invasive mask treatment. The measurements will last for about 8 to 14 hours at night while the patients are sleeping. In addition, the study will also include 2 healthy volunteers as a control group. They will have the equipment mounted on them for about 8 hours during the day in connection with normal office work. Follow up by telephone 7 days +/-2 days after the measurements are finished. The inclusion period is expected to be about 9 months.

Who can participate

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

Inclusion criteria

The subject must meet all of the following inclusion criteria at the time of enrolment:

EITHER

  • Patient are at risk of hypoventilation and thus carbon dioxide retention.
  • Either
  • Under evaluation for treatment with non-invasive ventilation and maybe Long term oxygen treatment due to chronic obstructive pulmonary disease or
  • Under evaluation for non-invasive ventilation support due to Obesity hypoventilation syndrome or due to a neuromuscular disorder.

OR

  • Healthy volunteers

ALL subjects:

  • Subject must be 18 years or older
  • Subject must be able to give written informed consent

Exclusion criteria

  • Known allergy to local anesthetics.
  • Participants should not have any kind of (direct or indirect) affiliation to Sensocure AS
  • Healthy volunteers: No heart-, lung-, or circulatory diseases, no bleeding disorder, no sleep disorders
  • Healthy volunteers should not have any kind of (direct or indirect) acquaintanceship to the investigators
  • Active smoker/use of snuff

Treatment and study plan

IscAlert sensor

Device

Insertion of an IscAlert sensor at the nasal mucosa

Primary outcomes

  1. Partial pressure (level) of carbon dioxide at the nasal mucosa

    Time frame: 14 hours

    Nasal mucosa's partial pressure of carbon dioxide (kPa) during insertion period

Secondary outcomes

  1. Bleeding

    Time frame: 7 days

    Amount of blood from insertion site (ml)

  2. Infection

    Time frame: 7 days

    Infection from insertion site at the discretion of the investigator (yes or no)

  3. Sinusitis

    Time frame: 7 days

    Developement of sinusitis at the discretion of the investigator (yes or no)

  4. Ulceration

    Time frame: 7 days

    Developement of ulceration at the nasal mucosa at the discretion of the investigator (yes or no)

  5. Pain at sensor insertion site

    Time frame: 7 days

    Pain at the insertion site measured by Numeric Rating Scale (0= no pain, 10= maximum pain)

Other outcomes

  1. Muscular temperature level

    Time frame: 14 hours

    Muscular temperature level (grade Celsius) during insertion period

  2. Nasal temperature level

    Time frame: 14 hours

    Nasal temperature level (grade Celsius) during insertion period

  3. Temporal temperature level

    Time frame: 14 hours

    Temporal temperature level (grade Celsius) during insertion period

  4. IscAlert functionality

    Time frame: 14 hours

    Number of hours with a well-functioning sensor (giving carbon dioxide- and temperature data)

  5. Number of pack-years

    Time frame: 7 days

    Smoking habit; number of pack-years by participants

  6. Length of sensor implantation time

    Time frame: 7 days

    Length of sensor implantation time during hospitalisation

  7. Peripheral oxygen saturation

    Time frame: 14 hours

    Peripheral oxygen saturation (SpO2)

  8. Arterial partial pressure (level) of carbon dioxide

    Time frame: 14 hours

    Arterial partial pressure of carbon dioxide (kPa) during insertion period - measured in arterial blood

  9. Arterial partial pressure (level) of oxygen

    Time frame: 14 hours

    Arterial partial pressure of oxygen (kPa) during insertion period - measured in arterial blood

  10. Intramuscular partial pressure (level) of carbon dioxide

    Time frame: 14 hours

    Intramuscular partial pressure of carbon dioxide (kPa) during insertion period - measured in the forearm

  11. Transcutaneous partial pressure (level) of carbon dioxide

    Time frame: 14 hours

    Transcutaneous partial pressure of carbon dioxide (kPa) during insertion period, measured at the skin of the forehead

  12. Patient-Reported Outcome Measures 1a - discomfort

    Time frame: 14 hours

    Discomfort in the nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  13. Patient-Reported Outcome Measures 1b - discomfort

    Time frame: 7 days

    Discomfort in the nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  14. Patient-Reported Outcome Measures 2a - runny nose

    Time frame: 14 hours

    Runny nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  15. Patient-Reported Outcome Measures 2b - runny nose

    Time frame: 7 days

    Runny nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  16. Patient-Reported Outcome Measures 3a - sneezing

    Time frame: 14 hours

    Sneezing - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  17. Patient-Reported Outcome Measures 3b - sneezing

    Time frame: 7 days

    Sneezing - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  18. Patient-Reported Outcome Measures 3b - Ulceration

    Time frame: 7 days

    Ulceration in the nose mucouse membrane - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  19. Patient-Reported Outcome Measures 3a - Ulceration

    Time frame: 14 hours

    Ulceration in the nose mucouse membrane - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  20. Patient-Reported Outcome Measures 4a - tenderness

    Time frame: 14 hours

    Tenderness in the nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  21. Patient-Reported Outcome Measures 4b - tenderness

    Time frame: 7 days

    Tenderness in the nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  22. Patient-Reported Outcome Measures 5b - bleeding

    Time frame: 7 days

    Bleeding from the nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  23. Patient-Reported Outcome Measures 5a - bleeding

    Time frame: 14 hours

    Bleeding from the nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  24. Patient-Reported Outcome Measures 6a - reduced sense of smell

    Time frame: 14 hours

    Reduced sense of smell - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  25. Patient-Reported Outcome Measures 6b - reduced sense of smell

    Time frame: 7 days

    Reduced sense of smell - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  26. Patient-Reported Outcome Measures 7b - reduced sense of taste

    Time frame: 7 days

    reduced sense of taste - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  27. Patient-Reported Outcome Measures 7a - reduced sense of taste

    Time frame: 14 hours

    reduced sense of taste - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  28. Patient-Reported Outcome Measures 8a - difficulty sleeping

    Time frame: 14 hours

    difficulty sleeping - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  29. Patient-Reported Outcome Measures 8b - easy to wake up while sleeping

    Time frame: 7 days

    easy to wake up while sleeping - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  30. Patient-Reported Outcome Measures 9 - problems with eating and drinking

    Time frame: 14 hours

    problems with eating and drinking - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  31. Patient-Reported Outcome Measures 10 - difficult breathing

    Time frame: 14 hours

    difficult breathing - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)

  32. Patient-Reported Outcome Measures 11a - diagnosed infection in the nose or sinuses

    Time frame: 14 hours

    diagnosed infection in the nose or sinuses - Patient-Reported Outcome Measure, Scale 1 to 2 (1= No, 2= Yes)

  33. Patient-Reported Outcome Measures 11b - diagnosed infection in the nose or sinuses

    Time frame: 7 days

    diagnosed infection in the nose or sinuses - Patient-Reported Outcome Measure, Scale 1 to 2 (1= No, 2= Yes)

Sponsors and collaborators

Lead sponsor

The Hospital of Vestfold

Other

Collaborators

  • Sensocure AS

Registry information

Official study title

Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor; The DISCO-study

Acronym: DISCO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
Jun 11, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.