Hot Flashes Clinical Trial
Official title:
Evaluation of a Novel Mechanical Device for Relief of Menopausal Vasomotor Symptoms.
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.
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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