Mechanical Device for the Relief of Hot Flashes

Hot Flashes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01281332
• Other study ID #: OBGY-208-10
• Status: Completed
• Phase: Phase 2
• First received: January 19, 2011
• Last updated: September 9, 2015
• Start date: September 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Device:
• Menopod
The mechanism of action of the device will not be revealed in advance.
• Inactive device

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Alexander Medical Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

Sloan JA, Loprinzi CL, Novotny PJ, Barton DL, Lavasseur BI, Windschitl H. Methodologic lessons learned from hot flash studies. J Clin Oncol. 2001 Dec 1;19(23):4280-90. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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).	No