What is the mechanism of action of this treatment?

Common treatments for Post-Traumatic Stress Disorder (PTSD) include pharmacologic therapies like SSRIs and SNRIs, which increase serotonin and norepinephrine levels to help regulate mood and anxiety. Non-pharmacologic treatments, such as trauma-focused cognitive behavioral therapy (CBT) and exposure therapy, help patients process traumatic memories and reduce avoidance behaviors. Digital therapeutic devices like NightWare aim to reduce nightmares by disrupting the sleep patterns associated with PTSD, thereby improving sleep quality and reducing symptoms. Understanding these mechanisms is crucial for tailoring treatment plans to individual needs, potentially improving outcomes and quality of life for PTSD patients.

What side effects are associated with this type of intervention?

Common treatments for PTSD include SSRIs and SNRIs, which can cause side effects such as nausea, insomnia, dizziness, and sexual dysfunction. Cognitive-behavioral therapy (CBT) is generally well-tolerated but may cause temporary increases in anxiety or distress as patients confront traumatic memories. Bright light therapy, sometimes used for sleep disturbances, can cause eye strain, headaches, and nausea. Digital therapeutic devices like NightWare, which are designed to reduce nightmares, are generally considered safe but may cause mild discomfort or adjustment issues initially.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of PTSD, primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications help alleviate general PTSD symptoms but are not specifically targeted at nightmares. For sleep disturbances and nightmares associated with PTSD, prazosin, an alpha-1 adrenergic antagonist, is commonly used, although it is not FDA-approved specifically for PTSD. Digital therapeutic devices like NightWare, which are being studied for their potential to reduce nightmares, represent a novel approach, but as of now, there are no FDA-approved digital therapeutics specifically for PTSD-related nightmares.

What other types of research exist?

Promising alternatives to NightWare for PTSD patients in 2024 include: 1) Hypnotic treatment, which has shown success in eliminating night terrors through posthypnotic suggestions. 2) Cognitive Behavioral Therapy for Insomnia (CBT-I), which has been effective in reducing insomnia severity and improving sleep metrics. 3) Wearable sleep monitoring devices like the Dreem 2 headband, which utilizes EEG technology to track and potentially improve sleep quality. These alternatives offer non-pharmacological approaches that can be tailored to individual needs.

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Behavioural Intervention

NightWare for PTSD

N/A

Waitlist Available

Led By Kerrie Moreau, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-report having repetitive nightmares contributing to disrupted sleep

Be older than 18 years old

Must not have

Uncontrolled hypertension

Diagnosis of narcolepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured before and after 6 weeks of nightware and sham conditions

Summary

This trial is testing NightWare, an app that works with an Apple Watch to help adults with PTSD who have nightmares. The app tracks sleep patterns and uses gentle vibrations to interrupt nightmares without waking the person. The goal is to see if this improves sleep quality and heart health.

Who is the study for?

Adults over 22 with PTSD and repetitive nightmares disrupting sleep, non-smokers, not currently using certain medications or supplements, with controlled blood pressure and glucose levels. Must have internet access for the device used in the trial and agree to avoid other heart rate monitoring apps.

What is being tested?

The study is testing NightWare, a therapeutic intervention aimed at improving sleep quality by reducing nightmares related to PTSD. It will be compared against a Sham (fake) NightWare to see if it can improve cardiovascular health markers.

What are the potential side effects?

Since NightWare is a digital therapeutic intervention focusing on improving sleep patterns through technology rather than medication, side effects are minimal but may include discomfort due to wearing the device or potential disruption of sleep from alerts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I often have nightmares that disturb my sleep.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My high blood pressure is not under control.

Select...

I have been diagnosed with narcolepsy.

Select...

I have been diagnosed with or suspected to have dementia.

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I have moderate to severe sleep apnea diagnosed or confirmed by a WatchPat test.

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I am currently taking varenicline, beta-blockers (not eye drops), or non-dihydropyridine medications.

Select...

I have diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured before and after 6 weeks of nightware and sham conditions

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured before and after 6 weeks of nightware and sham conditions

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured before and after 6 weeks of nightware and sham conditions for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 1utonomic function - BRS

Change in endothelial function

Change in large elastic artery stiffness -carotid artery

Secondary study objectives

Change in autonomic function - HRV

Change in large elastic artery stiffness

Other study objectives

Change in C-Reactive Protein

Change in CESD

Change in CSSR-S

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NightWareExperimental Treatment1 Intervention

In individuals randomized to the active condition, when the stress index is reached during sleep, NightWare will intervene with varying degrees of vibratory stimulation to the watch over a variable length of time to arouse the person out of the nightmare without awaking.

Group II: Sham NightWarePlacebo Group1 Intervention

In individuals randomized to the sham condition, the NightWare intervention will not be enabled.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NightWare

2022

N/A

~40

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Post-Traumatic Stress Disorder (PTSD) include pharmacologic therapies like SSRIs and SNRIs, which increase serotonin and norepinephrine levels to help regulate mood and anxiety. Non-pharmacologic treatments, such as trauma-focused cognitive behavioral therapy (CBT) and exposure therapy, help patients process traumatic memories and reduce avoidance behaviors. Digital therapeutic devices like NightWare aim to reduce nightmares by disrupting the sleep patterns associated with PTSD, thereby improving sleep quality and reducing symptoms. Understanding these mechanisms is crucial for tailoring treatment plans to individual needs, potentially improving outcomes and quality of life for PTSD patients.