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Mechanical Device for the Relief of Hot Flashes

This study has been completed.
Sponsor:
Collaborator:
Alexander Medical Inc.
Information provided by (Responsible Party):
Robert Reid, Queen's University
ClinicalTrials.gov Identifier:
NCT01281332
First received: January 19, 2011
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

Hypothesis: A mechanical device when applied to the back of the neck at the onset of a menopausal hot flash will attenuate the severity and duration of symptoms providing women with a reassuring non-hormonal intervention to improve quality of life in the menopausal transition. This pilot study will evaluate the effectiveness of this unit.

The mechanism of action of the device will not be revealed in advance.


Condition Intervention Phase
Hot Flashes
Device: Menopod
Device: Inactive device
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of a Novel Mechanical Device for Relief of Menopausal Vasomotor Symptoms.

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Hot flash score and duration [ Time Frame: Change from baseline to end of study (week 4). ] [ Designated as safety issue: No ]
    Hot flash score is a product of frequency x intensity (Sloan 2001). Duration (minutes) will be recorded in diary.


Secondary Outcome Measures:
  • Quality of Life (QOL) and Anxiety [ Time Frame: Change from baseline to end of study (week 4). ] [ Designated as safety issue: No ]

    Subjects will complete the Hot Flash Related Daily Interference Scale once during the evaluation phase and once per week over the four week treatment phase (Carpenter 2001). This validated questionnaire assesses the impact of hot flashes on daily activities and overall QOL. They will also complete the Zung Self-Rating Anxiety Scale (Zung 1971). This validated 20-item questionnaire measures anxiety with established normal, mild to moderate, marked to severe and extreme levels.

    Carpenter JS. The Hot Flash Related Daily Interference Scale: a tool for assessing the impact of hot flashes on quality of life following breast cancer. J Pain Symptom Manage 2001 Dec;22(6):979-89.

    Zung WW. A rating instrument for anxiety disorders. Psychosomatics 1971 Nov-Dec;12(6):371-9.



Enrollment: 40
Study Start Date: September 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Menopod device
Menopod®
Device: Menopod
The mechanism of action of the device will not be revealed in advance.
Sham Comparator: Sham device
Inactive device.
Device: Inactive device
Other Name: The mechanism of action of the active device is disabled.

Detailed Description:

This is a pilot study to test logistics and gather information for planning the definite trial. We will randomly allocate 40 subjects to receive either the active Menopod device (n=20) or a sham device with the mechanism disabled (n=20).

We will recruit menopausal women with moderate to severe hot flashes (as defined by FDA standards this means a minimum of 7 per day).

The two primary outcome parameters are the hot flash score which is the product of frequency x intensity (Sloan 2001), and the average duration (in minutes) of hot flash episodes over the course of one day. These outcomes will be self-recorded by subjects in a diary designed by our research team on five separate days throughout the course of the study, once during the evaluation phase and once per week over the four week treatment phase. The two summary measures will be the changes from baseline to the last record collected for hot flash scores and average durations. Delta values (assessment phase minus fourth treatment period) will be compared between the two treatment groups (active versus sham device) using t tests (IBM SPSS Statistics version 21).

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age range: 40 to 65 years
  • Healthy postmenopausal woman
  • natural or surgical menopause
  • FSH > 30 IU/L
  • Amenorrhea > 6 months prior to study
  • Minimum of 7 moderate hot flashes per day documented in diary during evaluation phase

Exclusion Criteria:

  • Any therapy for hot flashes prior to or during study
  • Obesity: BMI > 35
  • Alcohol abuse
  • Drug abuse
  • Unable to use device as per protocol
  • Unable to complete required documentation
  • Serious medical condition:
  • coronary heart disease
  • stroke
  • chronic renal or hepatic disease
  • diabetes
  • depression or other psychiatric illness
  • cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281332

Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2N6
Sponsors and Collaborators
Queen's University
Alexander Medical Inc.
Investigators
Principal Investigator: Robert L. Reid, MD Queen's University
  More Information

Publications:
Responsible Party: Robert Reid, Professor, Queen's University
ClinicalTrials.gov Identifier: NCT01281332     History of Changes
Other Study ID Numbers: OBGY-208-10
Study First Received: January 19, 2011
Last Updated: October 21, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
menopause
hot flash
quality of life

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 19, 2014