Actigraphy Sleep Parameters in Obstructive Sleep Apnea Patient's

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Polysomnography; Device: Actigraphy

• Registration Number: NCT03060915
• Lead Sponsor: Hospital Clinic of Barcelona

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-23
• Primary Completion: 2018-03
• Status Verified: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Polysomnography and actigraphy	Actigraphy	Polysomnography and actigraphy
Polysomnography and actigraphy	Polysomnography	Polysomnography and actigraphy

Primary Outcome Measures

Name	Time	Method
Sleep time (min)	3 months	To compare the outcomes acquired with the actigraphy with those acquired by the Polysomnography

Secondary Outcome Measures

Name	Time	Method
Wake time	3 months	To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.
sleep efficiency	3 months	To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.
sleep latency	3 months	To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain