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OpenTrials
Completed

NCT Number: NCT03523013

The Outcome of CPAP Titration Under Sleep Endoscopy

The outcome of CPAP titration under sleep endoscopy: A randomized controlled crossover trial

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Thoracic Medicine, Chang Gung Memorial Hospital

Taipei, 105, Taiwan

About this study

This is the study entitled "The outcome of CPAP titration under sleep endoscopy: A randomized controlled crossover trial". CPAP is first line golden standard treatment for Obstructive sleep apnea (OSA). However, the overall CPAP compliance is about 50%. One of the reasons responsible for the poor compliance is the inadequate pressure setting initially. Therefore, it is crucial for us to find out the adequate pressure as soon as possible. Sleep endoscopy is the way to evaluate upper airway obstruction of OSA patients. Meanwhile, the investigators used CPAP to titrate the adequate pressure to keep upper airway open under sleep endoscopy guidance. While the investigators find out this adequate pressure, the investigators set this pressure into CPAP program, which OSA patient will use for 1 month. To compare the different effect of CPAP under either auto-CPAP titration pressure or sleep endoscopy guidance pressure, those OSA patients will use auto-titration CPAP for 1 month as well. Another highlight of this study is the sedative agent-dexmedetomidine. Dexmedetomidine is a α2 antogonist, which cause patients sedative but less respiratory drive suppression. The mechanism of dexmedetomidine is more physiological for nature sleep.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • moderate to severe OSA
  • ESS >10

Exclusion criteria

  • ASA > 3
  • allergy to Dexmedetomidine
  • second or third degree AVB
  • severe heart failure Fc class IV
  • asthma acute attack

Treatment and study plan

CPAP

Device

CPAP treatment with different pressure for OSA patients

Primary outcomes

  1. complaince of CPAP use

    Time frame: the change of complaince between baseline, 1 month and 2 months

    CPAP complaince was defined as the use of CPAP is more than 4 hours per day and 5 days per week

Secondary outcomes

  1. sleepiness score

    Time frame: the change of ESS between baseline, 1 month and 2 months

    ESS

Other outcomes

  1. sleep quality

    Time frame: the change of PSQ between baseline, 1 month and 2 months

    PSQ

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

The Outcome of CPAP Titration Under Sleep Endoscopy: A Randomized Controlled Crossover Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 14, 2018
Registry last updated
Sep 30, 2020

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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