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Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Hyposafe device
Sponsored by
UNEEG Medical A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Healthy focused on measuring Evaluation of subcutaneous EEG recording

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy subjects
  • Age 18-70 years
  • For female participants: Not pregnant and, if child bearing potential, usage of reliable anti-contraceptive method during the study period

Exclusion Criteria:

  • Severe cardiac disease

    • History of myocardial infarction
    • Cardiac arrhythmia
  • Previous stroke or cerebral haemorrhage and any other structural cerebral disease
  • Active cancer or cancer diagnosis within the past five years
  • Uraemia defined as s-creatinine above 3 times upper reference value
  • Liver disease defined as s-alanine aminotransferase (s-ALAT) above 3 times upper reference interval
  • Epilepsy
  • Use of antiepileptic drugs for any purposes
  • Clinical important hearing impairment

  • Use of active implantable medical device including

    • Pacemaker and Implantable Cardioverter Defibrillator (ICD-unit)
    • Cochlear implant

  • Use of following drugs

    • Chemotherapeutic drugs of any kind
    • Methotrexate
    • Third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)
  • Abuse of alcohol (defined as consumption of > 250g alcohol (in Danish: 21 "genstande")) per week or abuse of any other neuro-active substances
  • Infection at the site of device-implantation
  • Any haemorrhagic disease
  • Diving (snorkel diving allowed) or parachute jumping
  • Patients that are judged incapable to understand the patient information or who are unlikely to complete the investigation for any reason
  • Persons operating MRI scanners.
  • Persons operating handheld transceivers for communication (e.g. within the police, medical, fire, air traffic control, marine or military).
  • Persons working at broadcast stations for television or FM/DAB radio.
  • Persons performing extreme sport.

Sites / Locations

  • Sydvestjysk Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sydvestjysk Hospital

Arm Description

Investigation of EEG recording with the Hyposafe device

Outcomes

Primary Outcome Measures

Performance: EEG Recordings - Impedance
The EEG performance was measured as the mean impedance as a function of time. An impedance value below 5 kOhm is considered very good.
Performance: EEG Quality
The power spectrum densities from the two modalities were directly compared on an integer scale from -5 to 5, where "-5" signifies that the scalp EEG was of much higher quality than the subcutaneous. "0" means they were of equal quality and "5" means the subcutaneous signal was of much higher quality
Performance: Continuous EEG
Average time of EEG recordings (hours/day)

Secondary Outcome Measures

Usability: Reported Discomfort During Day While Wearing the Device
The discomfort during the day was recorded by the study subject every day wearing the device. Reported discomfort was evaluated by the following question: "How much do you agree with the following statement: There has been no discomfort while wearing the HypoSafe device during day?". The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1).
Usability: Reported Discomfort During Night While Wearing the Device
The discomfort during the night was recorded by the study subject every night wearing the device. Reported discomfort was evaluated by the following question: "How much do you agree with the following statement: There has been no discomfort while wearing the HypoSafe device during night?". The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1).
Usability: Reported Discomfort Related to the Implant in the Beginning of the Study
The discomfort was recorded by the study subjects 19±4 days after implantation. Reported discomfort was evaluated by the following question: "How much do you agree with the following statement: I have not experienced any implant discomfort the past two days?". The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1).
Usability: Reported Discomfort Related to the Implant at the End of the Study
The discomfort was recorded by the study subjects 51±3 days after implantation. Reported discomfort was evaluated by the following question: "How much do you agree with the following statement: I have not experienced any implant discomfort the past two days?". The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1).

Full Information

First Posted
March 18, 2015
Last Updated
September 25, 2018
Sponsor
UNEEG Medical A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02402153
Brief Title
Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects
Official Title
Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNEEG Medical A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this pilot trial is to demonstrate the safety and the performance of the Hyposafe hypoglycaemia alarm device before conducting clinical trials in type 1 diabetes patients.
Detailed Description
Safety: To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm device. Performance: To evaluate the performance of the Hyposafe hypoglycaemia alarm device. Usability: To obtain information about the subjects use and acceptance of the Hyposafe Hypoglycaemia alarm device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Evaluation of subcutaneous EEG recording

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sydvestjysk Hospital
Arm Type
Other
Arm Description
Investigation of EEG recording with the Hyposafe device
Intervention Type
Device
Intervention Name(s)
Hyposafe device
Intervention Description
Subcutaneous EEG recorder for EEG measurements
Primary Outcome Measure Information:
Title
Performance: EEG Recordings - Impedance
Description
The EEG performance was measured as the mean impedance as a function of time. An impedance value below 5 kOhm is considered very good.
Time Frame
1 month
Title
Performance: EEG Quality
Description
The power spectrum densities from the two modalities were directly compared on an integer scale from -5 to 5, where "-5" signifies that the scalp EEG was of much higher quality than the subcutaneous. "0" means they were of equal quality and "5" means the subcutaneous signal was of much higher quality
Time Frame
1 month
Title
Performance: Continuous EEG
Description
Average time of EEG recordings (hours/day)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Usability: Reported Discomfort During Day While Wearing the Device
Description
The discomfort during the day was recorded by the study subject every day wearing the device. Reported discomfort was evaluated by the following question: "How much do you agree with the following statement: There has been no discomfort while wearing the HypoSafe device during day?". The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1).
Time Frame
1 month
Title
Usability: Reported Discomfort During Night While Wearing the Device
Description
The discomfort during the night was recorded by the study subject every night wearing the device. Reported discomfort was evaluated by the following question: "How much do you agree with the following statement: There has been no discomfort while wearing the HypoSafe device during night?". The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1).
Time Frame
1 month
Title
Usability: Reported Discomfort Related to the Implant in the Beginning of the Study
Description
The discomfort was recorded by the study subjects 19±4 days after implantation. Reported discomfort was evaluated by the following question: "How much do you agree with the following statement: I have not experienced any implant discomfort the past two days?". The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1).
Time Frame
19±4 days after implantation
Title
Usability: Reported Discomfort Related to the Implant at the End of the Study
Description
The discomfort was recorded by the study subjects 51±3 days after implantation. Reported discomfort was evaluated by the following question: "How much do you agree with the following statement: I have not experienced any implant discomfort the past two days?". The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1).
Time Frame
51±3 days after implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy subjects Age 18-70 years For female participants: Not pregnant and, if child bearing potential, usage of reliable anti-contraceptive method during the study period Exclusion Criteria: Severe cardiac disease History of myocardial infarction Cardiac arrhythmia Previous stroke or cerebral haemorrhage and any other structural cerebral disease Active cancer or cancer diagnosis within the past five years Uraemia defined as s-creatinine above 3 times upper reference value Liver disease defined as s-alanine aminotransferase (s-ALAT) above 3 times upper reference interval Epilepsy Use of antiepileptic drugs for any purposes Clinical important hearing impairment Use of active implantable medical device including Pacemaker and Implantable Cardioverter Defibrillator (ICD-unit) Cochlear implant Use of following drugs Chemotherapeutic drugs of any kind Methotrexate Third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine) Abuse of alcohol (defined as consumption of > 250g alcohol (in Danish: 21 "genstande")) per week or abuse of any other neuro-active substances Infection at the site of device-implantation Any haemorrhagic disease Diving (snorkel diving allowed) or parachute jumping Patients that are judged incapable to understand the patient information or who are unlikely to complete the investigation for any reason Persons operating MRI scanners. Persons operating handheld transceivers for communication (e.g. within the police, medical, fire, air traffic control, marine or military). Persons working at broadcast stations for television or FM/DAB radio. Persons performing extreme sport.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birger Thorsteinsson, MD, DMSc
Organizational Affiliation
Nordsjællands Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sydvestjysk Hospital
City
Esbjerg
ZIP/Postal Code
6800
Country
Denmark

12. IPD Sharing Statement

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