search
Back to results

Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken) (TNT/NW)

Primary Purpose

Stress Disorders, Post-Traumatic, Combat Disorders, Ptsd

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NightWare Therapeutic System
Sham NightWare
Sponsored by
NightWare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring PTSD, Nightmare, Nightmare Disorder, Post-traumatic stress disorder, Veteran, Digital therapeutic, Digital medicine

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Veteran Enrolled in the Minneapolis/St. Cloud VAHCS, or James A. Haley Veterans Administration Hospital at Tampa.
  • Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
  • Equal to or older than 22 years of age.
  • Proficient in both reading and writing in the English language.
  • Pittsburgh Sleep Quality Index (PSQI) score 10 or higher.
  • Epworth Sleepiness Scale (ESS): On question #8 any score above "0" will prompt an additional question: Do you drive ("get behind the wheel") when you are drowsy? The answer must be "No" to be enrolled in the study due to safety concerns.
  • Have repetitive nightmares contributing to disrupted sleep as reported by the patient
  • Wireless Internet and two power outlets where they sleep
  • 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.

Exclusion Criteria:

  • Patient Health Questionnaire-9 (PHQ-9) score greater than or equal to 20. A score of 1 or more on the suicide ideation item of the PHQ-9 will trigger a risk assessment.
  • Uncontrolled atrial fibrillation
  • Current use of varenicline
  • Current use of beta-blockers (unless ophthalmic solutions)
  • Current use of non-dihydropyridines
  • Current use of Prazosin for the treatment of nightmares (can include patients 2 days following taper and discontinuation) This would be coordinated with the prescribing provider
  • Circadian rhythm disruption on a regular basis (shift-work)
  • Known diagnosis of Obstructive Sleep Apnea
  • Diagnosis of an active disorder of arousal from non-rapid eye movement sleep
  • Diagnosis of rapid eye movement sleep behavior disorder
  • Diagnosis of narcolepsy
  • Alcohol Use Disorders Inventory Test (AUDIT) (score of 8 or higher)
  • Drug Abuse Screening Test-10 (DAST-10) (score greater than 2)
  • Suspicion of nightmares being secondary to substance abuse or withdrawal
  • Diagnosis or suspicion of dementia
  • Previous or foreseeable legal proceedings involving nightmares or trauma
  • Nocturia that causes awakening from sleep
  • Known sleepwalking
  • Acting out of dreams prior to PTSD trauma

Sites / Locations

  • James A. Haley Veterans Administration Hospital
  • Minneapolis VA Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment Arm

Sham Arm

Arm Description

Intervention with NightWare Therapeutic System

NightWare system set to not provide any interventions

Outcomes

Primary Outcome Measures

Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to Day 60
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. This outcome is the difference between the global score on the Pittsburgh Sleep Quality Index (PSQI) score at baseline (Day 0) and average global PSQI score across the four post-treatment initiation assessments (Days 14, 30, 44 and 60).

Secondary Outcome Measures

Full Information

First Posted
July 29, 2019
Last Updated
February 8, 2023
Sponsor
NightWare
Collaborators
Minneapolis Veterans Affairs Medical Center, Louis Stokes VA Medical Center, Walter Reed National Military Medical Center, Fort Belvoir Community Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04040387
Brief Title
Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)
Acronym
TNT/NW
Official Title
TNT/NW: Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 24, 2019 (Actual)
Primary Completion Date
August 24, 2024 (Anticipated)
Study Completion Date
August 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NightWare
Collaborators
Minneapolis Veterans Affairs Medical Center, Louis Stokes VA Medical Center, Walter Reed National Military Medical Center, Fort Belvoir Community Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will provide preliminary estimates of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application) for the treatment of nightmare disorder associated with post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with the NightWare digital therapeutic system. The investigators hypothesize that the NightWare digital therapeutic system will significantly improve sleep quality in participants with PTSD-Related nightmares and poor sleep quality.
Detailed Description
Nightmares are a common problem affecting 2-8% of the general population and a higher proportion of clinical populations. The negative consequences of untreated nightmares are significant and include impaired quality of life, sleep deprivation (often resulting in an increased intensity of nightmares), insomnia, daytime sleepiness, and fatigue. Untreated nightmares can also exacerbate the symptoms of underlying psychological dysfunction in people with depression and anxiety, leading to poor occupational and or social functioning. Nightmares can be idiopathic or associated with the use (or withdrawal) of certain medications or substances, or associated with disorders including PTSD. NightWare (Minneapolis, MN) has developed a novel approach to the treatment of nightmares. Through the use of a smartwatch-based application that senses physiologic parameters, the participant is aroused from sleep (without awakening the participant) so that the nightmare is interrupted prior to reaching a threshold of severity in which the participant would awaken in distress. Seconds later the participant returns to sleep without having experienced a nightmare. This approach avoids risk from pharmacological treatment, avoids exacerbation of symptoms from image rehearsal therapy and allows for a simple method with easily achieved adherence compared to existing treatments. The NightWare digital therapeutic system consists of a proprietary software application installed on a smartwatch. The application has been effective in focus groups when used on both Apple smartwatches and Motorola smartwatches. For the purposes of this study, the investigators will be using only the Apple (Cupertino, CA) 3rd generation smartwatch and the Apple iPhone. The NightWare application uses physiological markers obtained via the smartwatch to determine by proprietary algorithm whether a participant is in the early stages of a nightmare, but has not yet awoken in distress. As directed by the algorithm, the smartwatch then applies varying degrees of vibratory stimulation to the wrist over variable lengths of time with the intention of arousing the participant from sleep without eliciting an awakening.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Combat Disorders, Ptsd, Nightmare, Nightmares, REM-Sleep Type, Nightmare Disorder With Associated Non-Sleep Disorder
Keywords
PTSD, Nightmare, Nightmare Disorder, Post-traumatic stress disorder, Veteran, Digital therapeutic, Digital medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Intervention with NightWare Therapeutic System
Arm Title
Sham Arm
Arm Type
Sham Comparator
Arm Description
NightWare system set to not provide any interventions
Intervention Type
Device
Intervention Name(s)
NightWare Therapeutic System
Intervention Description
A wearable digital therapeutic system that will measure physiologic data when worn during sleep to deliver a mild vibration via the watch to elicit arousal thereby disrupting nightmares. This detection and stimulation sequence will be performed according to NightWare's proprietary algorithm.
Intervention Type
Device
Intervention Name(s)
Sham NightWare
Intervention Description
NightWare device not providing interventions
Primary Outcome Measure Information:
Title
Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to Day 60
Description
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. This outcome is the difference between the global score on the Pittsburgh Sleep Quality Index (PSQI) score at baseline (Day 0) and average global PSQI score across the four post-treatment initiation assessments (Days 14, 30, 44 and 60).
Time Frame
0-60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veteran Enrolled in the Minneapolis/St. Cloud VAHCS, or James A. Haley Veterans Administration Hospital at Tampa. Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Equal to or older than 22 years of age. Proficient in both reading and writing in the English language. Pittsburgh Sleep Quality Index (PSQI) score 10 or higher. Epworth Sleepiness Scale (ESS): On question #8 any score above "0" will prompt an additional question: Do you drive ("get behind the wheel") when you are drowsy? The answer must be "No" to be enrolled in the study due to safety concerns. Have repetitive nightmares contributing to disrupted sleep as reported by the patient Wireless Internet and two power outlets where they sleep 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. Exclusion Criteria: Patient Health Questionnaire-9 (PHQ-9) score greater than or equal to 20. A score of 1 or more on the suicide ideation item of the PHQ-9 will trigger a risk assessment. Uncontrolled atrial fibrillation Current use of varenicline Current use of beta-blockers (unless ophthalmic solutions) Current use of non-dihydropyridines Current use of Prazosin for the treatment of nightmares (can include patients 2 days following taper and discontinuation) This would be coordinated with the prescribing provider Circadian rhythm disruption on a regular basis (shift-work) Known diagnosis of Obstructive Sleep Apnea Diagnosis of an active disorder of arousal from non-rapid eye movement sleep Diagnosis of rapid eye movement sleep behavior disorder Diagnosis of narcolepsy Alcohol Use Disorders Inventory Test (AUDIT) (score of 8 or higher) Drug Abuse Screening Test-10 (DAST-10) (score greater than 2) Suspicion of nightmares being secondary to substance abuse or withdrawal Diagnosis or suspicion of dementia Previous or foreseeable legal proceedings involving nightmares or trauma Nocturia that causes awakening from sleep Known sleepwalking Acting out of dreams prior to PTSD trauma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel R Karlin, MD MA
Organizational Affiliation
NightWare
Official's Role
Study Chair
Facility Information:
Facility Name
James A. Haley Veterans Administration Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Minneapolis VA Healthcare System
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36305584
Citation
Davenport ND, Werner JK. A randomized sham-controlled clinical trial of a novel wearable intervention for trauma-related nightmares in military veterans. J Clin Sleep Med. 2023 Feb 1;19(2):361-369. doi: 10.5664/jcsm.10338.
Results Reference
derived

Learn more about this trial

Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)

We'll reach out to this number within 24 hrs