Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor (DISCO)

March 21, 2025 updated by: Anne-Marie Gabrielsen, The Hospital of Vestfold

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Norway
      • Tønsberg, Norway, 3103
        • Recruiting
        • Vestfold Hopsital Trust
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Morten Waldvogel-Rønning, MD
        • Sub-Investigator:
          • Caroline Sahlstrøm, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Nine patients will be selected consequtive from the hypoventilation assessment planning program at the site. Additionally, two healthy individuals, who have no heart-, lung-, or circulatory diseases, no bleeding disorder, no sleep disorders, and no ties whatsoever to the sponsor (Sensocure AS), will be included as volunteers. Otherwise completely freely chosen by the investigators except they must not have any kind of (direct or indirect) acquaintanceship to the investigators. Eligible subjects will be invited to participate in this clinical investigation. All the subjects will be included at least one day before study procedure starts.

Description

Inclusion Criteria:

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

EITHER

  1. Patient are at risk of hypoventilation and thus carbon dioxide retention.

  2. Either

    1. Under evaluation for treatment with non-invasive ventilation and maybe Long term oxygen treatment due to chronic obstructive pulmonary disease or
    2. Under evaluation for non-invasive ventilation support due to Obesity hypoventilation syndrome or due to a neuromuscular disorder.

    OR

  3. Healthy volunteers

    ALL subjects:

  4. Subject must be 18 years or older
  5. Subject must be able to give written informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Chronic obstructive pulmonary disease
3 Chronic obstructive pulmonary disease patients monitored with IscAlert sensor at nasal mucosa for 8-14 hours during the night
Device: IscAlert sensor
Insertion of an IscAlert sensor at the nasal mucosa
Neuromuscular disease
3 Neuromuscular disease patients monitored with IscAlert sensor at nasal mucosa for 8-14 hours during the night
Device: IscAlert sensor
Insertion of an IscAlert sensor at the nasal mucosa
Obesity hypoventilation syndrome
3 Obesity hypoventilation syndrome patients monitored with IscAlert sensor at nasal mucosa for 8-14 hours during the night
Device: IscAlert sensor
Insertion of an IscAlert sensor at the nasal mucosa
Healthy volunteers
2 healthy volunteers monitored with IscAlert sensor at nasal mucosa for approximately 8 hours during daytime
Device: IscAlert sensor
Insertion of an IscAlert sensor at the nasal mucosa

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
14 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: 7 days
Amount of blood from insertion site (ml)
7 days
Infection
Time Frame: 7 days
Infection from insertion site at the discretion of the investigator (yes or no)
7 days
Sinusitis
Time Frame: 7 days
Developement of sinusitis at the discretion of the investigator (yes or no)
7 days
Ulceration
Time Frame: 7 days
Developement of ulceration at the nasal mucosa at the discretion of the investigator (yes or no)
7 days
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)
7 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscular temperature level
Time Frame: 14 hours
Muscular temperature level (grade Celsius) during insertion period
14 hours
Nasal temperature level
Time Frame: 14 hours
Nasal temperature level (grade Celsius) during insertion period
14 hours
Temporal temperature level
Time Frame: 14 hours
Temporal temperature level (grade Celsius) during insertion period
14 hours
IscAlert functionality
Time Frame: 14 hours
Number of hours with a well-functioning sensor (giving carbon dioxide- and temperature data)
14 hours
Number of pack-years
Time Frame: 7 days
Smoking habit; number of pack-years by participants
7 days
Length of sensor implantation time
Time Frame: 7 days
Length of sensor implantation time during hospitalisation
7 days
Peripheral oxygen saturation
Time Frame: 14 hours
Peripheral oxygen saturation (SpO2)
14 hours
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
14 hours
Arterial partial pressure (level) of oxygen
Time Frame: 14 hours
Arterial partial pressure of oxygen (kPa) during insertion period - measured in arterial blood
14 hours
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
14 hours
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
14 hours
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)
14 hours
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)
7 days
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)
14 hours
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)
7 days
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)
14 hours
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)
7 days
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)
7 days
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)
14 hours
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)
14 hours
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)
7 days
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)
7 days
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)
14 hours
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)
14 hours
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)
7 days
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)
7 days
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)
14 hours
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)
14 hours
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)
7 days
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)
14 hours
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)
14 hours
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)
14 hours
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)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital of Vestfold

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sensocure AS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anne-Marie Gabrielsen, MD, PhD, The Hospital of Vestfold

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REK KULMU B 714179

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Disease, Chronic Obstructive

Clinical Trials on IscAlert sensor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings