Sympathetic Overactivity in Post-traumatic Stress Disorder

Part of paid clinical trials in Decatur, Georgia.

Sponsor
Emory University
Study ID
NCT01627301
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Device-Guided Breathing (DGB) — DEVICE
    The RESPeRATE device will be used for 15 minutes of device-guided breathing daily for 8 weeks. The participant places the elastic belt with a respiration sensor around the upper abdomen, and wears earbuds for audio feedback. The device monitors the breathing rate, calculates inspiration and expiration times, and generates a personalized melody of two distinct ascending and descending tones for inhalation versus exhalation. Users effortlessly entrain their breathing pattern with the tones, and the device gradually guides the user to a prolonged expiration time and slower respiratory rate (to \< 10 breaths/minute). The device automatically stores usage data, allowing for quantification of adherence and performance.
  • Sham DGB — DEVICE
    The sham device is identical to the DGB device, except it does not guide respiratory rates to slow down and instead maintains a rate of 14 breaths per minute. The sham device is used for 15 minutes per day for 8 weeks.
  • Transcutaneous Vagal Nerve Stimulation (tVNS) — DEVICE
    tVNS is a noninvasive method that involves placing a device over the skin overlying the vagus nerve on the neck. The device delivers mild electrical stimulation, using transcutaneous electrical nerve stimulation (TENS) unit. The stimulation is increased until there is a vibration and slight muscle contraction in the lower face or neck. Then the stimulation is delivered for 2 minutes on the left side of the neck, and on the right side of the neck, for a total of 4 minutes. The tVNS device is used twice daily for 8 weeks.
  • Sham tVNS — DEVICE
    Sham stimulation is delivered using a device that is identical to the gammaCore device but is programed to deliver a lower frequency that can be felt by the participant but does not actually stimulate the vagus nerve. The sham device is used twice daily for 8 weeks.

Study Details

Post-traumatic stress disorder (PTSD) is a highly prevalent anxiety disorder that is associated with an increased risk of cardiovascular (CV) disease and hypertension. One potential mechanism is overactivation of the sympathetic nervous system (SNS), both at rest and particularly during stress. This study will evaluate whether 8 weeks of daily DGB therapy or transcutaneous vagus nerve stimulation (tVNS) therapy improves SNS activity at rest and during stress.

Key Dates

Start date
Jul 31, 2012
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Device-guided Breathing (DGB)
    Participants randomized to the DGB group use a device to guide their breathing to a slow breathing rate.
  • Sham Comparator: Sham DGB
    Participants randomized to the sham DGB group use a device identical to the DGB device but respiratory rates are not guided lower than the physiological rate.
  • Experimental: Transcutaneous Vagal Nerve Stimulation (tVNS)
    Participants randomized to use a tVNS device to deliver mild electrical stimulation to the vagal nerve.
  • Sham Comparator: Sham tVNS
    Participants randomized to use the sham tVNS device which vibrates but does not stimulate the vagal nerve.

Primary Outcome Measure

Change in Muscle Sympathetic Nerve Activity (MSNA) Burst Frequency at Rest [ Time Frame: Baseline, Week 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical CenterDecaturGeorgia30033-

Find similar trials in Decatur, GA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Atlanta VA Medical Center· Decatur, GA

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