Obesity Hypoventilation Syndrome (OHS) Clinical Trials

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

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 110
View:

∙ 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

Locations
Other Locations
Norway
Vestfold Hopsital Trust
Tønsberg
Time Frame
Start Date: 2025-01-30
Completion Date: 2026-03-16
Participants
Target number of participants: 21
Treatments
Chronic obstructive pulmonary disease
3 Chronic obstructive pulmonary disease patients monitored with IscAlert sensor at nasal mucosa for 8-14 hours during the night
Neuromuscular disease
3 Neuromuscular disease patients monitored with IscAlert sensor at nasal mucosa for 8-14 hours during the night
Obesity hypoventilation syndrome
3 Obesity hypoventilation syndrome patients monitored with IscAlert sensor at nasal mucosa for 8-14 hours during the night
Healthy volunteers
2 healthy volunteers monitored with IscAlert sensor at nasal mucosa for approximately 8 hours during daytime
Sponsors
Leads: The Hospital of Vestfold
Collaborators: Sensocure AS

This content was sourced from clinicaltrials.gov