Heart Rate Variability Biofeedback for Female Sexual Arousal Disorder

October 10, 2018 updated by: University of Texas at Austin

Autonomic Imbalance and Female Sexual Arousal Disorder: The Identification of Heart Rate Variability Level as a Risk Factor and Treatment Target

Low resting heart rate variability (HRV) has been associated with sexual arousal problems and overall sexual dysfunction in women. Research has indicated that HRV biofeedback leads to increases in HRV as well as improvements in symptoms associated with several psychological disorders, some of which are comorbid with sexual arousal problems in women. Autogenic training also facilitates increases in HRV and was recently associated with acute increases in sexual arousal among sexually healthy women. The primary aim of the current study is to examine the efficacy of HRV biofeedback, with and without autogenic training, for the treatment of female sexual arousal disorder (FSAD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Women who meet ICD-10-CM diagnostic criteria for FSAD will be recruited and randomized into one of three conditions, HRV biofeedback (n = 25), HRV biofeedback plus autogenic training (n = 25), or wait-list control (n = 15). All participants will complete a baseline assessment, during which their resting state HRV and vaginal pulse amplitude (VPA) will be measured. The participants in the two biofeedback conditions will receive training in HRV biofeedback from the experimenter, and they will be provided with the materials necessary to guide self-practice in HRV biofeedback at home. Participants in these two conditions will be instructed to engage in at-home HRV biofeedback (with or without autogenic training) at least 5 times over a period of two weeks, during which they will report levels of arousal in a sexual activity diary. Participants in the wait-list control condition will report levels of arousal in a sexual activity diary. After two weeks, participants in all three conditions will return to the laboratory, where their physiological and psychological sexual arousal will be measured. Over the next two weeks, participants in the two biofeedback conditions will be asked to complete 5 more self-guided biofeedback sessions along with the sexual activity diary. Participants in all three conditions will return to the lab for a final assessment to measure post-treatment HRV and VPA levels as well as psychological sexual arousal. To our knowledge, this study will be the first randomized controlled trial of HRV biofeedback in women with sexual arousal problems. If the intervention increases arousal in this population, this study may offer a promising cost-effective psychosocial treatment for women with sexual arousal problems.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78751
        • The University of Texas at Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Premenopausal (18-40 years)
  • Fluent in English
  • Heterosexual or bisexual
  • Score of 26.55 or less on the Female Sexual Function Index (FSFI)
  • Current sexual arousal dysfunction
  • Ownership of an Elite HRV compatible device (recent iPhone, iPad, or Android)

Exclusion Criteria:

  • Pregnant or breastfeeding
  • History of or current sexually transmitted infections
  • History of major pelvic surgery
  • History of childhood sexual abuse
  • Currently taking androgens, estrogens, or other medical treatments to enhance sexual arousal
  • Current psychosis
  • If on antidepressants or antihypertensives, must be stabilized for at least 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: HRV Biofeedback
At home HRV biofeedback using mobile device
Behavioral: HRV Biofeedback
At-home heart rate variability biofeedback using Elite HRV app and Polar H7 chest strap
EXPERIMENTAL: HRV Biofeedback with Autogenic Training
At home HRV biofeedback using mobile device plus autogenic training recording
Behavioral: HRV Biofeedback
At-home heart rate variability biofeedback using Elite HRV app and Polar H7 chest strap
Behavioral: Autogenic Training
Autogenic training recording provided on a CD
NO_INTERVENTION: Wait List
Wait list control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Physiological sexual arousal assessed by vaginal photoplethysmography
Time Frame: One month
One month
Subjective sexual arousal assessed by Film Scale (Heiman & Rowland, 1983)
Time Frame: One month
One month
Sexual function assessed by Female Sexual Function Index (Rosen et al., 2000)
Time Frame: Two months
Two months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Depression symptoms assessed by Beck Depression Inventory-II (Beck, Brown, & Steer, 1996)
Time Frame: Two months
Two months
Anxiety symptoms assessed by Beck Anxiety Inventory (Beck et al., 1988)
Time Frame: Two months
Two months
Interoceptive awareness assessed by the Multidimensional Assessment of Interoceptive Awareness (Mehling et al., 2012)
Time Frame: Two months
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas at Austin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cindy M Meston, The University of Texas at Austin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-08-0074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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