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Effects of Continuous Positive Airway Pressure Therapy Withdrawal in Patients With Obstructive Sleep Apnea: A Randomized Trial

NCT05471765 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-07-25

No results posted yet for this study

Summary

Study design (e.g., double-blind:

A randomized, open-labeled, controlled, parallel-group study.

Sixty patients will be recruited with moderate to severe Obstructive Sleep Apnea (OSA), previously adherent to CPAP therapy and have controlled OSA defined as Apnea Hypopnea Index (AHI) of \< 5 while on treatment. Patients will be divided into two groups after completion of Therapeutic CPAP, Who will continue on same CPAP therapy for 4 weeks they will be randomized into two groups:

1. NO CPAP (NOCPAP Group): Who will stop using the CPAP device.
2. Intermittent CPAP (Int-CPAP Group): Who will use the CPAP device every other night.

This trial will also evaluate the effects of CPAP withdrawal (complete or partial) on excessive day time sleepiness (EDS), apnea hypopnea index (AHI), Heart Rate and Blood Pressure.

Conditions

Interventions

DEVICE

Withdrawal of Continuous Positive Airway Pressure device

After completing one month of therapeutic management with The Continuous Positive Airway Pressure device and have controlled OSA defined as Apnea Hypopnea Index (AHI) of \< 5 while on treatment. At random, a group of participants will cease to use the Continuous Positive Airway Pressure. And they'll have weakly clinic visits where they will fill the Epworth Sleepiness Scale, check their blood pressure, heart rate and undergo Polysomnography for 4 weeks.

DEVICE

Alternation usage of Continuous Positive Airway Pressure Device

After completing one month of therapeutic management with The Continuous Positive Airway Pressure device and have controlled OSA defined as Apnea Hypopnea Index (AHI) of \< 5 while on treatment. Randomly, these patients will alternatively use The Continuous Positive Airway Pressure device every other day (e.g. They will use the device 4 days and not use it for 3 days of the week) and they'll have weakly clinic visits where they will fill the Epworth Sleepiness Scale, check their blood pressure, heart rate and undergo Polysomnography for 4 weeks.

Sponsors & Collaborators

  • King Abdulaziz University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-23
Primary Completion
2022-11-30
Completion
2022-12-30

Countries

  • Saudi Arabia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05471765 on ClinicalTrials.gov