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| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
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This study is to analyze the breath metabolome before and after the administration of a placebo in an established experimental pain procedure in healthy subjects in order to investigate placebo effects, and whether they induce any measurable changes at the metabolic level.
Interrogation of the exhaled breath metabolome will be performed by using an objective method of measurement for placebo effects in pain analgesia, known as Cold Pressure Test (CPT). CPT reactions can be measured objectively by blood pressure spikes as well as changes in continuous heart rate monitoring.To this end, probands will be continuously connected to a Heartrate & Blood Pressure Monitor. First, baseline exhalation will be assessed. Then, the CPT is performed according to the 'CPT Guide' with subsequent post-pain exhalations analysis with or without self-administration of the placebo (NaCl nasal spray). After 15 minutes rest, probands will be submitted to a second post-pain exhalations set (+/- placebo). The process is completely non-invasive as the participant just exhales through a commercially available disposable bacterial/viral filter coupled to the ion source.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPT first | Other | Cold Pressor Test (CPT): apparatus for the task is a tank of water of temperature of 4 °C (+-0.5 °C), with instruction to immerse the hand until too uncomfortable to continue. A maximum time limit per immersion of 3-5 min is applied. Quantitative measurement can then be made of pain threshold (point first perceived as painful) and tolerance time. All 20 participants will undergo two study visits. The order in which they will receive CPT and CPT plus placebo differs, with participants being randomly split into two groups. 10 participants first CPT + placebo and then CPT, and 10 participants vice versa. |
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| CPT+placebo first | Other | Participant will be told and read about the 'pain medication' (= Placebo NaCl Nasal spray). Thereafter participant will self-administer a nasal spray, which is in fact a placebo nasal spray containing NaCl solution and Cold Pressor Test (CPT) is performed. All 20 participants will undergo two study visits. The order in which they will receive CPT and CPT plus placebo differs, with participants being randomly split into two groups. 10 participants first CPT + placebo and then CPT, and 10 participants vice versa |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold Pressor Test (CPT) | Other | Cold Pressor Test (CPT): apparatus for the task is a tank of water of temperature of 4 °C (+-0.5 °C), with instruction to immerse the hand until too uncomfortable to continue. A maximum time limit per immersion of 3-5 min is applied. Quantitative measurement can then be made of pain threshold (point first perceived as painful) and tolerance time. |
| Measure | Description | Time Frame |
|---|---|---|
| change in signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites | The variable of primary interest is the variation of signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites. | 1 hour |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Sinues, Prof. Dr. | Universitäts-Kinderspital beider Basel (UKBB) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäts-Kinderspital beider Basel (UKBB) | Basel | Canton of Basel-City | 4056 | Switzerland |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 24, 2025 | |
| Reset | Aug 8, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 24, 2025 | Aug 8, 2025 |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Single centered; national ,randomized, crossover, pilot study
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participants do not know its a placebo
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| Placebo NaCl Nasal spray | Other | placebo nasal spray containing NaCl solution |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |