Actigraphy Sleep Parameters in Obstructive Sleep Apnea Patient's

Obstructive Sleep Apnea Clinical Trial

Official title:

Comparison of Actigraphy Sleep Parameters vs Polysomnography Sleep Parameters in OSA Patient's

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060915
• Other study ID #: ACT_2017
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Polysomnography
Patient's undergo a polysomnography
• Actigraphy
Patient's wear an actigraphy while doing the polysomnography

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep time (min)	To compare the outcomes acquired with the actigraphy with those acquired by the Polysomnography	3 months
Secondary	sleep efficiency	To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.	3 months
Secondary	Wake time	To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.	3 months
Secondary	sleep latency	To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.	3 months