Mechanical Device for the Relief of Hot Flashes

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Evaluation of a Novel Mechanical Device for Relief of Menopausal Vasomotor Symptoms.

Conditions
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Hot Flashes

Intervention / Treatment
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* Device: Menopod
* Device: Inactive device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Menopod device<br>Menopod® | Device: Menopod<br>* The mechanism of action of the device will not be revealed in advance.<br>|
| Sham Comparator: Sham device<br>Inactive device. | Device: Inactive device<br> <br> * Other names: The mechanism of action of the active device is disabled.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flash score and duration | Hot flash score is a product of frequency x intensity (Sloan 2001). Duration (minutes) will be recorded in diary. | Change from baseline to end of study (week 4). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QOL) and Anxiety | 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. | Change from baseline to end of study (week 4). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopause, hot flash, quality of life