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Behavioural Intervention

Digital Therapeutic for Sleep in Post-Traumatic Stress Disorder (TNT/NW Trial)

N/A
Waitlist Available
Research Sponsored by NightWare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prazosin use; if yes, the patient may be included if tapered by prescribing provider. Taper must be completed and subject must be off prazosin for 2 days prior to enrollment.
Equal to or older than 22 years of age.
Must not have
Diagnosis of rapid eye movement sleep behavior disorder
Diagnosis of narcolepsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-60 days
Awards & highlights

Summary

This trial will test a new digital therapeutic system for people with PTSD-related nightmares and poor sleep quality. The system includes an iPhone, Apple Watch, and a proprietary app. The investigators hope that the system will significantly improve sleep quality.

Who is the study for?
This trial is for adults over 22 with PTSD-related nightmares disrupting sleep, a PSQI score of 10+, and no current use of certain medications like varenicline or beta-blockers. Participants need internet, power outlets by their bed, and can't have conditions like sleep apnea or narcolepsy. Veterans in specific VA hospitals are eligible.Check my eligibility
What is being tested?
The study tests the NightWare system (iPhone + Apple Watch app) against a sham device to see if it improves sleep quality for those with PTSD-related nightmares. It's hypothesized that NightWare will significantly enhance sleep.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort from wearing the device at night, possible skin irritation from the watch band, and any unforeseen reactions to being awakened during sleep.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have stopped taking prazosin 2 days before joining.
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I am 22 years old or older.
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I am 22 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a sleep disorder where I act out dreams.
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I have been diagnosed with narcolepsy.
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I have been diagnosed with a sleep disorder affecting my non-REM sleep.
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I am currently taking non-dihydropyridine medication.
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I have atrial fibrillation that is not well-managed.
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I wake up at night needing to urinate.
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I am currently taking beta-blockers, not including eye drops.
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I have been diagnosed with or suspected to have dementia.
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I am currently taking varenicline.
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I have been diagnosed with Obstructive Sleep Apnea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to Day 60

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
Intervention with NightWare Therapeutic System
Group II: Sham ArmPlacebo Group1 Intervention
NightWare system set to not provide any interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NightWare Therapeutic System
2019
N/A
~100

Find a Location

Who is running the clinical trial?

James A. Haley Veterans Administration HospitalFED
20 Previous Clinical Trials
12,887 Total Patients Enrolled
NightWareLead Sponsor
4 Previous Clinical Trials
526 Total Patients Enrolled
Minneapolis Veterans Affairs Medical CenterFED
74 Previous Clinical Trials
15,679 Total Patients Enrolled

Media Library

NightWare Therapeutic System (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04040387 — N/A
Nightmare Disorder Research Study Groups: Treatment Arm, Sham Arm
Nightmare Disorder Clinical Trial 2023: NightWare Therapeutic System Highlights & Side Effects. Trial Name: NCT04040387 — N/A
NightWare Therapeutic System (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04040387 — N/A
~0 spots leftby Aug 2024