Pill Study Hyperthermia Device (Heckel HT 3000): Monitoring Core Body Temperature Using Wireless Technology

NCT02340377 | Terminated

• 1 other identifier: 14-11566-046
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the proposed study is to determine the use of a wireless method to monitor and record core body temperature during a Whole Body Hyperthermia treatment, compared to an indwelling rectal thermometer. This protocol is intended to study the differences between a rectal temperature probe and an approved wireless and indigestible thermometer during a WBH session. The current standard in monitoring core body temperature is the usage of an indwelling rectal thermometer. Many patients and potential study subjects, however, decline receiving the treatment, due to the discomfort of using this measuring method and a wireless measuring device would open the possibility for those patients to receive a treatment. The primary endpoint for example of a treatment for MDD is currently defined with reaching a rectal temperature of 38.5 C. However, due to the proximity of the probe to the body's surface, the core body temperature will vary from the rectal temperature and the comparison between the two methods with a validation of the wireless device is necessary. The investigators will monitor subject's physiological outcome from a single Whole Body Hyperthermia treatment in an open fashion (no placebo/control condition). This study will include safety assessments 7 days several days prior to or same day as the WBH, and include follow-up assessments 1 day and 1 week later.

Conditions

Core Body Temperature

Keywords

core body temperature; whole-body hyperthermia; rectal body temperature

Outcome Measures

Primary Outcomes (1)

• Difference in core body temperature

  Core body temperature differences as measured by 1) a rectal temperature probe and 2) an approved wireless and indigestible thermometer during a WBH session.

  WBH Heating Session (this takes place at the hospital and lasts approximately 2.5 hours)

Secondary Outcomes (3)

• Change in Score on the Q-LESQ-SF (Quality of Life Enjoyment and Satisfaction Questionnaire -Short form)

  WBH treatment day and 1 day following WBH treatment

• Change in Score on the Positive and Negative Association Scale (PANAS)

  During the WBH Session

• Change in Score on Cognition Tests

  WBH treatment day and 1 day following WBH treatment

Interventions

ELITE 3 HQ DEVICE

The pill is about the size of a multivitamin, is coated with special medical plastic, and is easy to swallow. The pill sends radio signals to a small recording device that participants wear that send a signal to a monitor and records the participant's internal body temperature. The pill will exit the participant's body in one of his/her bowel movements approximately 1-5 days after ingestion. Pills are not reused.

Also known as: Core body temperature indigestible measuring device

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

For the purposes of this study we will enroll subjects 18-50 years of age to undergo a Hyperthermia session in an open fashion. We expect approximately 20 - 30 subjects to undergo this open hyperthermia treatment. Subjects must be medically healthy enough to be able to undergo the Hyperthermia session, all exclusion criteria listed below address what is deemed "medically healthy", per self-report by potential subjects. There will be no inclusion of children, pregnant women, mentally impaired individuals, or prisoners in this study.

You may qualify if:

• Male or females aged 18-50 years.
• Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
• Able to communicate in English with study personnel.
• For women of child-bearing potential (i.e., one who is biologically capable of become pregnant,) must be willing to use a medically acceptable form of birth control or practice abstinence for the duration of her participation in the trial per self-report.

You may not qualify if:

• Any of the following diagnoses, as identified by the psychiatric evaluation or study assessments:
• A current DSM-IV-TR Axis I diagnosis of Dementia; or
• Any current DSM-IV-TR Axis II diagnosis (i.e. personality disorder) that would suggest potential noncompliance with the protocol; or
• A lifetime history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder Type 1; or
• A diagnosis claustrophobia severe enough that it would impair ability to be in the Heckel HT3000 hyperthermia device
• A current (or within 6 months prior to the Screening visit) diagnosis of Anorexia Nervosa or Bulimia Nervosa
• Individuals with psychiatric diagnoses may be excluded per the investigator's discretion.
• If patient has a medical condition or disorder that:
• Is unstable and clinically significant, or:
• Could, in the investigator's opinion, interfere with the accurate assessment of safety or efficacy of the procedure, including:
• individuals who are using prescription drugs that may impair thermoregulatory cooling,
• individuals with cardiovascular conditions or problems (uncontrolled hypertension, congestive heart failure, or documented evidence of coronary artery disease)
• individuals with chronic conditions/diseases associated with a reduced ability initiate thermoregulatory cooling, including Parkinson's, multiple sclerosis, central nervous system tumors, and diabetes with neuropathy,
• individuals with a fever the day of study intervention (if so, they will be rescheduled),
• individuals with hypersensitivity to heat,

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Study Officials

• Charles Raison, MD

  University of Arizona, Department of Psychiatry, College of Medicine

  PRINCIPAL INVESTIGATOR

• Clemens Janssen, MS

  University of Arizona, Department of Psychiatry, College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry; College of Medicine

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 16, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 10, 2015

Record last verified: 2015-08

Locations

US (1)