Back to resultsActigraphy Sleep Parameters in Obstructive Sleep Apnea Patient's
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Polysomnography
Actigraphy
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea focused on measuring Actigraphy, Polysomnography, Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Patient's with OSA suspicion undergoing a PSG in the sleep unit
Exclusion Criteria:
- Neurologic disorders
- Severe comorbidities
- Other sleep disorders, such as insomnia
- No informed consent
Sites / Locations
- Hospital Clinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Polysomnography and actigraphy
Arm Description
Polysomnography and actigraphy
Outcomes
Primary Outcome Measures
Sleep time (min)
To compare the outcomes acquired with the actigraphy with those acquired by the Polysomnography
Secondary Outcome Measures
sleep efficiency
To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.
Wake time
To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.
sleep latency
To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.
Full Information
NCT ID
NCT03060915
First Posted
February 10, 2017
Last Updated
March 29, 2019
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT03060915
Brief Title
Actigraphy Sleep Parameters in Obstructive Sleep Apnea Patient's
Official Title
Comparison of Actigraphy Sleep Parameters vs Polysomnography Sleep Parameters in OSA Patient's
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Actigraphy, Polysomnography, Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polysomnography and actigraphy
Arm Type
Other
Arm Description
Polysomnography and actigraphy
Intervention Type
Device
Intervention Name(s)
Polysomnography
Intervention Description
Patient's undergo a polysomnography
Intervention Type
Device
Intervention Name(s)
Actigraphy
Intervention Description
Patient's wear an actigraphy while doing the polysomnography
Primary Outcome Measure Information:
Title
Sleep time (min)
Description
To compare the outcomes acquired with the actigraphy with those acquired by the Polysomnography
Time Frame
3 months
Secondary Outcome Measure Information:
Title
sleep efficiency
Description
To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.
Time Frame
3 months
Title
Wake time
Description
To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.
Time Frame
3 months
Title
sleep latency
Description
To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient's with OSA suspicion undergoing a PSG in the sleep unit
Exclusion Criteria:
Neurologic disorders
Severe comorbidities
Other sleep disorders, such as insomnia
No informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Maria Montserrat, MD
Organizational Affiliation
Hospital Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Actigraphy Sleep Parameters in Obstructive Sleep Apnea Patient's
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