InsomniaNCT02463461
Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography
A study testing ActiSleep Activity Monitor, Jawbone Activity Monitor and Actiwatch 2 Activity Monitor in people with Insomnia, run by Weill Medical College of Cornell University.
Trial summary
The primary objective of the proposed study is to investigate the agreement levels of modern and well-established actigraphy devices against PSG in healthy as well as patient populations for multiple sleep parameters across two study sites (Qatar and New York City). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Insomnia
- What is being tested?
- ActiSleep Activity Monitor, Jawbone Activity Monitor and Actiwatch 2 Activity Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Attending a regularly scheduled Polysomnography test at Weill Cornell Medical College. Male or female. 18-80 years old
Who cannot join
- Not attending a regularly scheduled Polysomnography test at Weill Cornell Medical College. Under 18 or over 80 years old. Pregnancy. Unable to provide informed consent.
About this study
The primary objective of the proposed study is to investigate the agreement levels of modern and well-established actigraphy devices against PSG in healthy as well as patient populations for multiple sleep parameters across two study sites (Qatar and New York City).
Read the detailed description
The importance of sleep upon physiological and psychological health has been extensively documented. It has been proposed that adequate sleep, as well as good sleep quality, is vital for wellbeing. (1). Some have suggested that sleep curtailment has paralleled the increased prevalence of cardiometabolic disease including obesity (2), type 2 diabetes mellitus (3, 4), hypertension (5, 6) and more. Sleep researchers face a major challenge since there are multiple methods for sleep assessment, all of which have advantages and disadvantages.Whilst polysomnography (PSG) is considered to be the gold standard for sleep assessment, there are some limitations including laboratory attendance for the participant and sleep scoring variance. Sleep questionnaires are widely utilized, particularly in large epidemiological studies, but are susceptible to inaccuracies and some have not been validated against PSG. Wrist actigraphy has provided researchers with an attractive equivalent and there are now multiple commercial manufacturers available. Actigraphic devices are usually worn on the non-dominant wrist and the instrument is used to monitor wrist movements through the use of an accelerometer and a memory chip. Wrist actigraphy is useful in the detection of sleep, wake, and activity.
- Conditions
- Insomnia
- Being tested
- ActiSleep Activity Monitor, Jawbone Activity Monitor, Actiwatch 2 Activity Monitor, FitBit Activity Monitor, Actigraph by Ambulatory Monitoring Activity Monitor
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiSleep Activity MonitorDevice
Subjects in this group will wear a ActiSleep Activity Monitor.
Jawbone Activity MonitorDevice
Subjects in this group will wear a Jawbone Activity Monitor.
Actiwatch 2 Activity MonitorDevice
Subjects in this group will wear a Actiwatch 2 Activity Monitor.
FitBit Activity MonitorDevice
Subjects in this group will wear a FitBit Activity Monitor.
Actigraph by Ambulatory Monitoring Activity MonitorDevice
Subjects in this group will wear a Actigraph by Ambulatory Monitoring Activity Monitor.
| Study group | Role | What they receive |
|---|---|---|
| ActiSleep Activity Monitor | Experimental | Subjects placed in this group will given an ActiSleep Activity Monitor for the one night of the study. Receives: Device: ActiSleep Activity Monitor |
| Jawbone Activity Monitor | Experimental | Subjects placed in this group will given a Jawbone Activity Monitor for the one night of the study. Receives: Device: Jawbone Activity Monitor |
| Actiwatch 2 Activity Monitor | Experimental | Subjects placed in this group will given an Actiwatch 2 Activity Monitor for the one night of the study. Receives: Device: Actiwatch 2 Activity Monitor |
| FitBit Activity Monitor | Experimental | Subjects placed in this group will given a FitBit Activity Monitor for the one night of the study. Receives: Device: FitBit Activity Monitor |
| Actigraph by Ambulatory Monitoring Activity Monitor | Experimental | Subjects placed in this group will given an Actigraph by Ambulatory Monitoring Activity Monitor for the one night of the study. Receives: Device: Actigraph by Ambulatory Monitoring Activity Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time (TST)
The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.
Measured: 1 night
Secondary outcomes (1)
Wake After Sleep Onset (WASO)
(Wake After Sleep Onset) Total minutes of wakefulness recorded after Sleep Onset, as scored by epochs.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: Not sure if we are going to do this study now.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Cornell Medical College in Qatar
- Responsible party
- Sponsor
- Investigators
- Ana Krieger, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463461
- Sponsor's protocol ID
- 1406015180
- Status last verified
- May 2017
- First submitted
- 13 Jan 2015
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography
- ClinicalTrials.gov ID
- NCT02463461
- Acronym / sponsor ID
- 1406015180
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not sure if we are going to do this study now.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Weill Cornell Medical College in Qatar
- Study start
- Aug 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 4 Jun 2015 (estimated)
- 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.
The primary objective of the proposed study is to investigate the agreement levels of modern and well-established actigraphy devices against PSG in healthy as well as patient populations for multiple sleep parameters across two study sites (Qatar and New York City).
Detailed description
The importance of sleep upon physiological and psychological health has been extensively documented. It has been proposed that adequate sleep, as well as good sleep quality, is vital for wellbeing. (1). Some have suggested that sleep curtailment has paralleled the increased prevalence of cardiometabolic disease including obesity (2), type 2 diabetes mellitus (3, 4), hypertension (5, 6) and more. Sleep researchers face a major challenge since there are multiple methods for sleep assessment, all of which have advantages and disadvantages.Whilst polysomnography (PSG) is considered to be the gold standard for sleep assessment, there are some limitations including laboratory attendance for the participant and sleep scoring variance. Sleep questionnaires are widely utilized, particularly in large epidemiological studies, but are susceptible to inaccuracies and some have not been validated against PSG. Wrist actigraphy has provided researchers with an attractive equivalent and there are now multiple commercial manufacturers available. Actigraphic devices are usually worn on the non-dominant wrist and the instrument is used to monitor wrist movements through the use of an accelerometer and a memory chip. Wrist actigraphy is useful in the detection of sleep, wake, and activity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ActiSleep Activity Monitor | Experimental | Device: ActiSleep Activity MonitorSubjects placed in this group will given an ActiSleep Activity Monitor for the one night of the study. |
| Jawbone Activity Monitor | Experimental | Device: Jawbone Activity MonitorSubjects placed in this group will given a Jawbone Activity Monitor for the one night of the study. |
| Actiwatch 2 Activity Monitor | Experimental | Device: Actiwatch 2 Activity MonitorSubjects placed in this group will given an Actiwatch 2 Activity Monitor for the one night of the study. |
| FitBit Activity Monitor | Experimental | Device: FitBit Activity MonitorSubjects placed in this group will given a FitBit Activity Monitor for the one night of the study. |
| Actigraph by Ambulatory Monitoring Activity Monitor | Experimental | Device: Actigraph by Ambulatory Monitoring Activity MonitorSubjects placed in this group will given an Actigraph by Ambulatory Monitoring Activity Monitor for the one night of the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Attending a regularly scheduled Polysomnography test at Weill Cornell Medical College. Male or female. 18-80 years old
Key exclusion criteria (1 listed)
- Not attending a regularly scheduled Polysomnography test at Weill Cornell Medical College. Under 18 or over 80 years old. Pregnancy. Unable to provide informed consent.
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 |
|---|---|---|
| ActiSleep Activity MonitorSubjects in this group will wear a ActiSleep Activity Monitor. | Device | ActiSleep Activity Monitor |
| Jawbone Activity MonitorSubjects in this group will wear a Jawbone Activity Monitor. | Device | Jawbone Activity Monitor |
| Actiwatch 2 Activity MonitorSubjects in this group will wear a Actiwatch 2 Activity Monitor. | Device | Actiwatch 2 Activity Monitor |
| FitBit Activity MonitorSubjects in this group will wear a FitBit Activity Monitor. | Device | FitBit Activity Monitor |
| Actigraph by Ambulatory Monitoring Activity MonitorSubjects in this group will wear a Actigraph by Ambulatory Monitoring Activity Monitor. | Device | Actigraph by Ambulatory Monitoring Activity Monitor |
Primary outcome
Total sleep time (TST)
Time frame: 1 night
The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.
1 secondary outcome
Wake After Sleep Onset (WASO)
Time frame: 1 Year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Ana Krieger principal investigator
Weill Medical College of Cornell University
Questions about this trial
What is this clinical trial studying?
A study testing ActiSleep Activity Monitor, Jawbone Activity Monitor and Actiwatch 2 Activity Monitor in people with Insomnia, run by Weill Medical College of Cornell University.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Total sleep time (TST) (time frame: 1 night). 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 10 May 2017.