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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
Summary
This trial tests the NightWare system, which uses an Apple Watch and iPhone app to help people with PTSD-related nightmares. The watch detects when a nightmare is starting and vibrates to stop it without waking the person up. This aims to improve sleep quality for those who suffer from frequent nightmares.
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.
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.
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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-60 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
12,937 Total Patients Enrolled
NightWareLead Sponsor
4 Previous Clinical Trials
526 Total Patients Enrolled
Minneapolis Veterans Affairs Medical CenterFED
76 Previous Clinical Trials
16,068 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a sleep disorder where I act out dreams.You have been diagnosed with PTSD based on the criteria set by the American Psychiatric Association in their DSM-5 manual.You have a high score of 10 or more on the Pittsburgh Sleep Quality Index, indicating poor sleep quality.I have been diagnosed with narcolepsy.You have a history of acting out your dreams before experiencing a traumatic event that caused PTSD.I have stopped taking prazosin 2 days before joining.I have stopped taking prazosin 2 days before joining the trial.I have nightmares often that disturb my sleep.You have a high score on a test that measures alcohol use disorder.I have been diagnosed with a sleep disorder affecting my non-REM sleep.You have a high score on a drug abuse screening test, indicating possible drug abuse.I am currently using Prazosin for nightmares, or stopped it within the last 2 days.You have a history of sleepwalking.I am currently taking non-dihydropyridine medication.I have atrial fibrillation that is not well-managed.I wake up at night needing to urinate.You have nightmares that might be caused by using or stopping certain drugs.Your sleep quality, as measured by the PSQI, is 10 or higher.If your PHQ-9 score is 20 or higher, or if you have any thoughts of hurting yourself, you will need to go through a risk assessment.I am currently taking beta-blockers, not including eye drops.I have been diagnosed with or suspected to have dementia.I am 22 years old or older.I am currently taking varenicline.You work night shifts or have irregular sleep patterns that disrupt your body's natural sleep-wake cycle.I have been diagnosed with Obstructive Sleep Apnea.I am 22 years old or older.You have been involved in legal proceedings related to nightmares or trauma, or there is a possibility of future legal proceedings related to nightmares or trauma.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
- Group 2: Sham Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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