Trial Outcomes & Findings for Reducing the Experience of Menopausal Symptoms Through Temperature (NCT NCT03937466)

Results Overview

Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

baseline

Results posted on

2022-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Cooling Mattress Pad Subjects will use a cooling mattress pad nightly for approximately 8 weeks Cooling mattress pad: The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.
Overall Study STARTED	38
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Cooling Mattress Pad Subjects will use a cooling mattress pad nightly for approximately 8 weeks Cooling mattress pad: The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.
Overall Study not eligbile after the 2-week diary	9
Overall Study never returned their diary	6
Overall Study dropped out of study before getting Chilipad	5
Overall Study 3 did not complete follow-up questionnaire.	3

Baseline Characteristics

Reducing the Experience of Menopausal Symptoms Through Temperature

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Cooling Mattress Pad n=15 Participants Subjects will use a cooling mattress pad nightly for approximately 8 weeks Cooling mattress pad: The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.
Age, Continuous	53.2 years STANDARD_DEVIATION 3.9 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.

Outcome measures

Outcome measures
Measure	Experimental Cooling Mattress Pad n=15 Participants Subjects will use a cooling mattress pad nightly for approximately 8 weeks Cooling mattress pad: The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.
Hot Flash Diary	9 number of hot flashes per week Standard Deviation 4.5

PRIMARY outcome

Timeframe: Week 10

Population: 4 participants did not fill out hot flash diary at week 10

Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.

Outcome measures

Outcome measures
Measure	Experimental Cooling Mattress Pad n=11 Participants Subjects will use a cooling mattress pad nightly for approximately 8 weeks Cooling mattress pad: The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.
Hot Flash Diary	4.5 number of hot flashes per week Standard Deviation 3.0

PRIMARY outcome

Timeframe: baseline

The hot flash severity index score is a weighted total that combines number of hot flashes and severity using a 4- point severity scale from 1= mild to 4= very severe for each hot flash. Severity is calculated by multiplying the number of hot flashes by each level of severity. For example, 5 mild hot flashes would create a score of 5 and 3 very severe hot flashes would have a score of 12.

Outcome measures

Outcome measures
Measure	Experimental Cooling Mattress Pad n=15 Participants Subjects will use a cooling mattress pad nightly for approximately 8 weeks Cooling mattress pad: The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.
Hot Flash Severity Index Score	20.0 score on a scale Standard Deviation 10.4

PRIMARY outcome

Timeframe: Week 10

Population: 4 did not fill out hot flash diaries at week 10

The hot flash severity index score is a weighted total that combines number of hot flashes and severity using a 4- point severity scale from 1= mild to 4= very severe for each hot flash. Severity is calculated by multiplying the number of hot flashes by each level of severity. For example, 5 mild hot flashes would create a score of 5 and 3 very severe hot flashes would have a score of 12.

Outcome measures

Outcome measures
Measure	Experimental Cooling Mattress Pad n=11 Participants Subjects will use a cooling mattress pad nightly for approximately 8 weeks Cooling mattress pad: The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.
Hot Flash Severity Index Score	7.8 score on a scale Standard Deviation 6.4

SECONDARY outcome

Timeframe: baseline

Population: 1 person did not answer all PSQI items at baseline, so data not included here.

Questionnaire that assesses the subjects' quality of sleep through their answers to 19 questions on sleep quality. The global score ranges from 0 to 16 with a score \>5 indicating poor sleep quality.

Outcome measures

Outcome measures
Measure	Experimental Cooling Mattress Pad n=14 Participants Subjects will use a cooling mattress pad nightly for approximately 8 weeks Cooling mattress pad: The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.
Pittsburgh Sleep Quality Index (PSQI)	11.14 score on a scale Standard Deviation 3.16

SECONDARY outcome

Timeframe: Week 10

Questionnaire that assesses the subjects' quality of sleep through their answers to 19 questions on sleep quality. The global score ranges from 0 to 16 with a score \>5 indicating poor sleep quality

Outcome measures

Outcome measures
Measure	Experimental Cooling Mattress Pad n=15 Participants Subjects will use a cooling mattress pad nightly for approximately 8 weeks Cooling mattress pad: The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.
Pittsburgh Sleep Quality Index (PSQI)	7.87 score on a scale Standard Deviation 3.50

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: follow up at 11 weeks

Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: follow up at 11 weeks

Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: follow up at 11 weeks

Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

Questionnaire that assesses subject symptom sensitivity. Scores range 10-50 with a lower score being better.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and week 11

Anxiety symptoms will be measured with the GAD-7, which consists of 7 items, each describing a common symptom of anxiety. The respondent rates how much he or she has been bothered by each symptom over the past two weeks on a 4-point scale ranging from 0 to 3. Higher scores indicate more anxiety.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

Questionnaire that allows the study team to record baseline behaviors

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: follow up at 11 weeks

Questionnaire that allows the study team to evaluate the subject's perception of how well the intervention worked.

Outcome measures

Outcome data not reported

Adverse Events

Experimental Cooling Mattress Pad

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy Avis, PhD

Wake Forest University School of Medicine

Phone: 336-716-6974

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place