Obstructive Sleep ApneaNCT03060915
Actigraphy Sleep Parameters in Obstructive Sleep Apnea Patient's
A study testing Polysomnography and Actigraphy in people with Obstructive Sleep Apnea, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Those patient's that come to the sleep unit and that accept to participate in the study will undergo a polysomnography with the extra of an actigraphy placed in their no dominant arm wrist. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Polysomnography and Actigraphy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2016to Mar 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's with OSA suspicion undergoing a PSG in the sleep unit
Who cannot join
- Neurologic disorders
- Severe comorbidities
- Other sleep disorders, such as insomnia
- No informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Actigraphy Sleep Parameters vs Polysomnography Sleep Parameters in OSA Patient's
Those patient's that come to the sleep unit and that accept to participate in the study will undergo a polysomnography with the extra of an actigraphy placed in their no dominant arm wrist. The outcomes that will be analyzed are:
Time in bed, assumed sleep time, wake time, sleep efficiency, sleep latency, light's on/light's off
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Polysomnography, Actigraphy
- Keywords
- Actigraphy, Polysomnography, Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDevice
Patient's undergo a polysomnography
ActigraphyDevice
Patient's wear an actigraphy while doing the polysomnography
| Study group | Role | What they receive |
|---|---|---|
| Polysomnography and actigraphy | Other | Polysomnography and actigraphy Receives: Device: Polysomnography; Device: Actigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep time (min)
To compare the outcomes acquired with the actigraphy with those acquired by the Polysomnography
Measured: 3 months
Secondary outcomes (3)
sleep efficiency
To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.
Measured: 3 months
Wake time
To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.
Measured: 3 months
sleep latency
To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startSep 2016
- Primary completionMar 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose M. Montserrat, Hospital Clinic of Barcelona
- Investigators
- Josep Maria Montserrat, MD, Principal investigator, Hospital Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060915
- Sponsor's protocol ID
- ACT_2017
- Status last verified
- Mar 2019
- First submitted
- 10 Feb 2017
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Actigraphy Sleep Parameters vs Polysomnography Sleep Parameters in OSA Patient's
- ClinicalTrials.gov ID
- NCT03060915
- Acronym / sponsor ID
- ACT_2017
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Actigraphy, Polysomnography, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 23 Feb 2017 (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.
Those patient's that come to the sleep unit and that accept to participate in the study will undergo a polysomnography with the extra of an actigraphy placed in their no dominant arm wrist. The outcomes that will be analyzed are:
Time in bed, assumed sleep time, wake time, sleep efficiency, sleep latency, light's on/light's off
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polysomnography and actigraphy | Other | Device: Polysomnography, Device: ActigraphyPolysomnography and actigraphy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient's with OSA suspicion undergoing a PSG in the sleep unit
Key exclusion criteria (4 listed)
- Neurologic disorders
- Severe comorbidities
- Other sleep disorders, such as insomnia
- No 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 |
|---|---|---|
| PolysomnographyPatient's undergo a polysomnography | Device | Polysomnography and actigraphy |
| ActigraphyPatient's wear an actigraphy while doing the polysomnography | Device | Polysomnography and actigraphy |
Primary outcome
Sleep time (min)
Time frame: 3 months
To compare the outcomes acquired with the actigraphy with those acquired by the Polysomnography
3 secondary outcomes
sleep efficiency
Time frame: 3 months
Wake time
Time frame: 3 months
sleep latency
Time frame: 3 months
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 1 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Josep Maria Montserrat, MD principal investigator
Hospital Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography and Actigraphy in people with Obstructive Sleep Apnea, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 4 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 1 Apr 2019. 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 Spain. 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?
Sleep time (min) (time frame: 3 months). 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 1 Apr 2019.