Sleep DisordersNCT02260297
A Study of Wrist Actigraphy in Overweight and Obese Adults With Sleep Disorders
An observational study of Sleep Disorders, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
70 overweight or obese adults with sleep disorders will be recruited for this study, in which the investigators aim to compare wrist actigraphy with polysomnography (PSG) for sleep monitoring. It is to evaluate the applications of Jawbone Up2 with the sleep parameters derived from this actigraphy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- Wrist Actigraphy(motion sensors)with light sensors-Jawbone Up 2
- Type of treatment
- Medical device
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Oct 2014
- Phase
- Observational
- 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
Study population: Overweight and obese adults with sleep disorders
Who may be able to join
- 18 years of age or older
- Have one or more sleep disorders such as consecutive snoring, insomnia, sleep apnea, narcolepsy, delayed sleep phase syndrome
- Athens Insomnia Scale (AIS)>6
- BMI>25
- Agree to participate in the study and have signed the inform consent form
Who cannot join
- Terminal illness
- Physically-challenged and paralyzed patients
- Intend to receive selective surgery, to get pregnancy and breast feeding in three months
- Long-term use of the sleeping pills
- Hearing loss or severe visual disorder;
- Mental disorders
- Dementia or communication disorders
- Unable to complete an all night sleep monitoring
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
70 overweight or obese adults with sleep disorders will be recruited for this study, in which the investigators aim to compare wrist actigraphy with polysomnography (PSG) for sleep monitoring. It is to evaluate the applications of Jawbone Up2 with the sleep parameters derived from this actigraphy.
Read the detailed description
As an observation study, it will recruit 70 overweight or obese patients with sleep disorders who meet the selection criteria: clinical records and AIS at a tertiary hospital. The patients will sign the informed consent form. The involved patients and doctors will receive related training.
These patients will receive the sleep monitoring from 21:00 to 6:00 in sleep monitoring laboratory in Ruijin Hospital. They will receive the PSG and Jawbone Up 2 sleep monitoring at the same time. Sleep parameters derived from actigraphy and PSG will be compared in multiple night recordings such as total sleep time, wake after sleep onset, sleep onset latency, awakening, sleep efficiency, total time in bed,. The aim is to assess the validation of actigraphy in overweight or obese patients with sleep disorders.
- Conditions
- Sleep Disorders
- Being tested
- Wrist Actigraphy(motion sensors)with light sensors-Jawbone Up 2
- Keywords
- Actigraphy, overweight and obese adults, sleep disorders
- Medical subject headings
- Sleep Wake Disorders, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist Actigraphy(motion sensors)with light sensors-Jawbone Up 2Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time, TST
Measured: 10 hrs
Wake After Sleep Onset, WASO
Measured: 10 hrs
Secondary outcomes (3)
Sleep Onset Latency, SOL
Measured: 10 hrs
Frequency of arousal during sleep,awakenings
Measured: 10 hrs
Sleep Efficiency, SE
Measured: 10 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260297
- Sponsor's protocol ID
- CCEMD-023
- Status last verified
- Dec 2014
- First submitted
- 5 Oct 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Wrist Actigraphy in Overweight and Obese Adults With Sleep Disorders
- ClinicalTrials.gov ID
- NCT02260297
- Acronym / sponsor ID
- CCEMD-023
- Conditions
- Sleep Disorders
- Keywords
- Actigraphy, overweight and obese adults, sleep disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Ruijin Hospital
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 9 Oct 2014 (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.
70 overweight or obese adults with sleep disorders will be recruited for this study, in which the investigators aim to compare wrist actigraphy with polysomnography (PSG) for sleep monitoring. It is to evaluate the applications of Jawbone Up2 with the sleep parameters derived from this actigraphy.
Detailed description
As an observation study, it will recruit 70 overweight or obese patients with sleep disorders who meet the selection criteria: clinical records and AIS at a tertiary hospital. The patients will sign the informed consent form. The involved patients and doctors will receive related training.
These patients will receive the sleep monitoring from 21:00 to 6:00 in sleep monitoring laboratory in Ruijin Hospital. They will receive the PSG and Jawbone Up 2 sleep monitoring at the same time. Sleep parameters derived from actigraphy and PSG will be compared in multiple night recordings such as total sleep time, wake after sleep onset, sleep onset latency, awakening, sleep efficiency, total time in bed,. The aim is to assess the validation of actigraphy in overweight or obese patients with sleep disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Overweight and obese adults with sleep disorders
Key inclusion criteria (5 listed)
- 18 years of age or older
- Have one or more sleep disorders such as consecutive snoring, insomnia, sleep apnea, narcolepsy, delayed sleep phase syndrome
- Athens Insomnia Scale (AIS)>6
- BMI>25
- Agree to participate in the study and have signed the inform consent form
Key exclusion criteria (8 listed)
- Terminal illness
- Physically-challenged and paralyzed patients
- Intend to receive selective surgery, to get pregnancy and breast feeding in three months
- Long-term use of the sleeping pills
- Hearing loss or severe visual disorder;
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 |
|---|---|---|
| Wrist Actigraphy(motion sensors)with light sensors-Jawbone Up 2 | Device | – |
Primary outcome
Total Sleep Time, TST
Time frame: 10 hrs
Wake After Sleep Onset, WASO
Time frame: 10 hrs
3 secondary outcomes
Sleep Onset Latency, SOL
Time frame: 10 hrs
Frequency of arousal during sleep,awakenings
Time frame: 10 hrs
Sleep Efficiency, SE
Time frame: 10 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorders, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 3 Dec 2014. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 10 hrs). The study lists 2 primary outcomes in all. 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 3 Dec 2014.