PostTraumatic Stress DisorderNWOESNCT03828656
NightWare Open Enrollment Study
A study testing NightWare Therapeutic System in people with PostTraumatic Stress Disorder and Sleep Disorder, run by NightWare at 1 site in United States.
Trial summary
This study will provide measures 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PostTraumatic Stress Disorder, Sleep Disorder, Stress Disorder
- What is being tested?
- NightWare Therapeutic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New to NightWare
- Self report of diagnosis with PTSD
- Self-report of PTSD-related repetitive nightmares contributing to disrupted sleep.
- Equal to or older than 18 years of age.
- Proficient in both reading and writing in the English language.
- Pittsburgh Sleep Quality Index (PSQI) score equal to or greater than 10.
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- ESS: On question #8 any score above "0" will prompt an additional question:
- Do you drive ("get behind the wheel") when you are drowsy?
- Answer must be "No" to be enrolled in the study for safety.
- Participant owns or has access to devices appropriate for participation in the study including compatible Apple Watch and Apple iPhone.
- Wireless Internet and two power outlets where they sleep.
- OR
- Current NightWare user - Is a participant in current NightWare consumer preference study or has successfully completed any NightWare study protocol.
Who cannot join
- New to NightWare
- Circadian rhythm disruption on a regular basis (shift-work)
- Concurrent presence of prohibited diagnoses
- Known diagnosis of OSA
- Diagnosis of an active disorder of arousal from non-rapid eye movement sleep
- Diagnosis of rapid eye movement sleep behavior disorder
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- Diagnosis of narcolepsy
- Diagnosis of dementia
- Uncontrolled atrial fibrillation
- Use of Alcohol or Drugs as specified:
- 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
- Previous or foreseeable legal proceedings involving nightmares or trauma
- Nocturia that causes awakening from sleep
- Known sleep walking
- Acting out of dreams PRIOR to PTSD trauma
- Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare.
- OR
- Current NightWare User
- No known adverse reaction to the use of the NightWare system.
Trial locations and contacts
1 site in 1 country.
About this study
This study will provide measures 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.
Read the 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.
- Conditions
- PostTraumatic Stress Disorder, Sleep Disorder, Stress Disorder, Sleep Initiation and Maintenance Disorders, Combat Disorders, Nightmares Associated With Chronic Post-Traumatic Stress Disorder
- Being tested
- NightWare Therapeutic System
- Keywords
- PTSD, Nightmare Disorder, Post-traumatic stress disorder, Veteran, Digital therapeutic, Digital medicine, Nightmares
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Wake Disorders, Stress Disorders, Traumatic, Sleep Initiation and Maintenance Disorders, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NightWare Therapeutic SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Open Label Treatment Arm | Experimental | Open-label Intervention with the NightWare Therapeutic System every night. Receives: Device: NightWare Therapeutic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to each subsequent 28 day evaluation period
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 post-treatment initiation assessments (Days 14, 28 and every 28 days after that).
Measured: 0-730 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Feb 2019
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostTraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NightWare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RationalPsych, Center for International Emergency Medical Services
- Responsible party
- Sponsor
- Investigators
- Daniel R Karlin, MD MA, Principal investigator, RationalPsych
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828656
- Sponsor's protocol ID
- NW101003
- Acronym
- NWOES
- Status last verified
- Mar 2021
- First submitted
- 31 Jan 2019
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NightWare Open Enrollment Study
- ClinicalTrials.gov ID
- NCT03828656
- Acronym / sponsor ID
- NWOES / NW101003
- Conditions
- PostTraumatic Stress Disorder, Sleep Disorder, Stress Disorder, Sleep Initiation and Maintenance Disorders, Combat Disorders, Nightmares Associated With Chronic Post-Traumatic Stress Disorder
- Keywords
- PTSD, Nightmare Disorder, Post-traumatic stress disorder, Veteran, Digital therapeutic, Digital medicine, Nightmares
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- NightWareIndustry (pharma, biotech, devices)
- Collaborators
- RationalPsych, Center for International Emergency Medical Services
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will provide measures 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Treatment Arm | Experimental | Device: NightWare Therapeutic SystemOpen-label Intervention with the NightWare Therapeutic System every night. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- New to NightWare
- Self report of diagnosis with PTSD
- Self-report of PTSD-related repetitive nightmares contributing to disrupted sleep.
- Equal to or older than 18 years of age.
- Proficient in both reading and writing in the English language.
Key exclusion criteria (21 listed)
- New to NightWare
- Circadian rhythm disruption on a regular basis (shift-work)
- Concurrent presence of prohibited diagnoses
- Known diagnosis of OSA
- Diagnosis of an active disorder of arousal from non-rapid eye movement sleep
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NightWare Therapeutic SystemA 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. | Device | Open Label Treatment Arm |
Primary outcome
Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to each subsequent 28 day evaluation period
Time frame: 0-730 days
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 post-treatment initiation assessments (Days 14, 28 and every 28 days after that).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel R Karlin, MD MA principal investigator
RationalPsych
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NightWare Therapeutic System in people with PostTraumatic Stress Disorder and Sleep Disorder, run by NightWare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to each subsequent 28 day evaluation period (time frame: 0-730 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.