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

NCT05471765 | Unknown DMC

• 1 other identifier: 241-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Achieving a desaturation SPO2 index of >10 or AHI of >5

  Achieving a desaturation SPO2 index of \>10 or AHI of \>5

  six months

Secondary Outcomes (1)

• Recurrence of excessive sleepiness daytime symptoms

  six months

Other Outcomes (1)

• Primary safety endpoint (study stopping rules): The study will be discontinued for any participants if any of the following developed

  six months

Study Arms (2)

Moderate Obstructive Sleep Apnea

EXPERIMENTAL

Patients whom have an apnea/hypopnea index above fifteen are classified to have moderate obstructive sleep apnea

Device: Withdrawal of Continuous Positive Airway Pressure device; Device: Alternation usage of Continuous Positive Airway Pressure Device

Severe Obstructive Sleep Apnea

EXPERIMENTAL

Patients whom have an apnea/hypopnea index with a result higher than thirty are considered to have severe obstructive sleep apnea

Device: Withdrawal of Continuous Positive Airway Pressure device; Device: Alternation usage of Continuous Positive Airway Pressure Device

Interventions

Withdrawal of Continuous Positive Airway Pressure device 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.

Moderate Obstructive Sleep Apnea; Severe Obstructive Sleep Apnea

Alternation usage of Continuous Positive Airway Pressure Device 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.

Moderate Obstructive Sleep Apnea; Severe Obstructive Sleep Apnea

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20 and 75 years, AHI \> 15 based on PSG An Epworth Sleepiness Scale (ESS) of \>10, (At base line before treatment ) Stable BMI: defines as BMI that has been stable with no more than 10 % changes. Currently on CPAP therapy for more than or equal of 6 months Compliance with CPAP defined as more than 4 hours per night for an average of 5 nights per week or ≥ 70% of all recorded days Current ESS score of \<10.

You may not qualify if:

• Patients with ventilatory failure, Cheyne-Stokes breathing, unstable and untreated coronary or peripheral artery disease, severe and inadequately controlled arterial hypertension, or a history of any sleep-related accident, or who were current professional drivers, were excluded from the study

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University Hospital

Jeddah, 22230, Saudi Arabia

RECRUITING

Related Publications (1)

• Wali SO, Batawi G, Kanbr O, Butt NS, Yasawy MA, Alqaidi D, Alhejaili F, Alshumrani R, Gozal D. Impact of continuous positive airway pressure therapy withdrawal in patients with obstructive sleep apnea: a randomized controlled trial. Sleep Breath. 2025 Apr 1;29(2):146. doi: 10.1007/s11325-025-03309-z.

  PMID: 40167853 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Siraj O Wali, Professor

CONTACT

0126408222; sowali@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Sleep Medicine and Research Center, Professor of Medicine

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 25, 2022
• Study Start: March 23, 2020
• Primary Completion: November 30, 2022
• Study Completion: December 30, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)