NightWare for Post-Traumatic Stress Disorder

Not yet recruiting at 1 trial location

Overseen By Kerrie Moreau, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Antihypertensives, Lipid-lowering, Insulin, others

Disqualifiers: Diabetes, Hypertension, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a new treatment called NightWare might help women with PTSD-related nightmares sleep better and improve their heart and kidney health. NightWare gently interrupts nightmares without fully waking the person. The trial includes two main groups: one will use NightWare, and the other will use a non-functional version of the device (a placebo). Women with PTSD who experience disruptive nightmares and poor sleep quality may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore a novel treatment option for enhancing sleep and overall health.

Do I need to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications, such as vitamins, supplements, and anti-inflammatory medications, at least 2 weeks before the first visit. Additionally, you cannot use medications that affect heart or kidney function, like blood pressure or cholesterol medications.

What prior data suggests that the NightWare device is safe for use in women with PTSD-related nightmares?

Research shows that NightWare has already received FDA approval to help reduce sleep problems caused by traumatic nightmares, confirming its safety for those experiencing nightmares. The device gently vibrates to interrupt nightmares without fully waking the person.

NightWare does not replace other PTSD treatments, but it is generally easy to use without major issues. Few reports of serious side effects exist. Users should continue taking prescribed medications and engaging in other PTSD therapies. This combined approach helps ensure the best overall care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about NightWare because it offers a novel approach to managing PTSD-related nightmares. Unlike standard treatments like cognitive behavioral therapy or medication, NightWare is a digital therapeutic that uses a smartwatch to detect nightmares through biometric data. When it senses a nightmare, it delivers gentle vibrations to disrupt the nightmare without fully waking the user. This non-invasive intervention could provide relief without the side effects associated with medications, offering a new avenue for those struggling with sleep disturbances due to PTSD.

What evidence suggests that NightWare is effective for PTSD-related nightmares?

Research has shown that NightWare, a digital therapy system, may improve sleep for individuals with PTSD-related nightmares. In this trial, participants using the experimental NightWare treatment, which intervenes with vibratory stimulation during nightmares, reported their sleep quality improved more than twice as much as those in the sham NightWare group, which received a fake treatment. This suggests NightWare might effectively reduce sleep problems caused by nightmares. The device gently interrupts nightmares without fully waking the user, thereby enhancing overall sleep. While initial results are promising, further research is needed to fully understand its benefits. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for premenopausal women with PTSD-related nightmares, confirmed by specific PTSD scales. Participants should be healthy based on their medical history and have poor sleep quality due to repetitive nightmares. Women without PTSD or prior trauma exposure are also needed for a control group.

Inclusion Criteria

I am generally healthy according to my medical history.

I meet the specific eligibility criteria for my group.

I have been diagnosed with PTSD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline testing for vascular and renal function, and sleep quality assessments

1 week

1 visit (in-person)

Treatment

Participants receive NightWare or sham intervention for 8 weeks

8 weeks

Weekly check-ins (virtual)

Follow-up

Participants are monitored for changes in vascular and renal function, and sleep quality after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NightWare

Trial Overview The study tests NightWare, a therapeutic intervention aimed at improving biomarkers of vascular and renal function in women with PTSD-related nightmares. It will compare the effects of NightWare against a sham (inactive) version to see if it can restore health markers to levels seen in women without PTSD.

How Is the Trial Designed?

Group I: Experimental NightWare Experimental Treatment 1 Intervention

In women with PTSD-related nightmares 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 awakening.

Group II: Control Women without PTSD-related Nightmares Active Control 1 Intervention

Age-matched women without PTSD-related nightmares will complete baseline testing only (no intervention).

Group III: Sham NightWare Placebo Group 1 Intervention

In women with PTSD-related nightmares randomized to the sham condition, the NightWare intervention will not be enabled

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Ludeman Family Center for Women's Health Research

Collaborator

Trials

1

Recruited

20+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9892731/

A randomized sham-controlled clinical trial of a novel ... Overall, these results provide preliminary evidence that a wearable device may improve self-reported sleep quality for veterans reporting frequent trauma- ...

2. nightware.com nightware.com/wp-content/uploads/2021/08/NIGHTWARE-CLINICAL-DATA-OVERVIEW.pdf

NIGHTWARE CLINICAL INFORMATION NightWare is a digital therapeutic system that temporarily reduces sleep disturbance related to nightmares. NightWare provides customized medical treatment for ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03934658

Remote Study of NightWare for PTSD With Nightmares This study will provide measures of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application) for the ...

4. uchealth.org uchealth.org/today/study-can-nightware-help-people-with-ptsd/

Study: Can NightWare help people with PTSD? NightWare may or may not be one of those PTSD treatment augments, Holliday said, but data about its effectiveness were “initially promising.

5. nightware.com nightware.com/professionals/

Professionals The PSQI-A change was 3.3 points, more than double that of the sham condition (1.4 points). Given that this measure specifically indexes sleep disturbances ...

6. nightware.com nightware.com/important-safety-information/

Important Safety Information NightWare is not a standalone therapy for PTSD. The device should be used in conjunction with prescribed medications for PTSD and other recommended therapies ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN200033.pdf

DEN200033 Decision Summary - accessdata.fda.gov The NightWare device is not intended to be used as a standalone therapy for PTSD and should be used in conjunction with a patient's prescribed medications and ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04040387

Traumatic Nightmares Treated by NightWare (To Arouse ... This study will provide preliminary estimates of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary ...

9. nightware.com nightware.com/professionals-faq/

Professionals FAQ Based on its review of all data submitted by the company, in November 2020 the FDA cleared NightWare for the reduction of sleep disturbance related to ...