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OpenTrials
Completed

NCT Number: NCT03060915

Actigraphy Sleep Parameters in Obstructive Sleep Apnea 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

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Device

Patient's undergo a polysomnography

Actigraphy

Device

Patient's wear an actigraphy while doing the polysomnography

Primary outcomes

  1. Sleep time (min)

    Time frame: 3 months

    To compare the outcomes acquired with the actigraphy with those acquired by the Polysomnography

Secondary outcomes

  1. sleep efficiency

    Time frame: 3 months

    To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.

  2. Wake time

    Time frame: 3 months

    To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.

  3. sleep latency

    Time frame: 3 months

    To evaluate the agreement, sensitivity and specificity between the outcomes acquired by the Polysomnography and by the actigraphy.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Feb 23, 2017
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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