Obstructive Sleep ApneaNCT05471765
Effects of Continuous Positive Airway Pressure Therapy Withdrawal in Patients With Obstructive Sleep Apnea: A Randomized Trial
A study testing Withdrawal of Continuous Positive Airway Pressure device and Alternation usage of Continuous Positive Airway Pressure Device in people with Obstructive Sleep Apnea, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Withdrawal of Continuous Positive Airway Pressure device and Alternation usage of Continuous Positive Airway Pressure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 23 Mar 2020to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdulaziz University Hospital
Jeddah, 22230
Siraj O Wali, Professor, 0126408222 ext. 1640, sowali@kau.edu.sa
About this study
Study design (e.g., double-blind:
A randomized, open-labeled, controlled, parallel-group study.
Read more
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:
- NO CPAP (NOCPAP Group): Who will stop using the CPAP device.
- 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.
Read the detailed description
Obstructive sleep apnea syndrome (OSAS) is a common sleep-related breathing disorder, which is characterized by transient interruption of ventilation during sleep caused by complete or partial collapse of the upper airway. Many risk factors are identified such as: male gender, large neck circumference, smoking, excessive alcohol intake and high Body Mass Index (BMI).
The prevalence of OSAS in Saudi Arabia is about 4% and 1.8% in males and females, respectively, and it is associated with many comorbidities like type 2 DM, ischemic heart disease, congestive heart failure, hypertension and depression.
Continuous positive airway pressure (CPAP) is considered the gold standard treatment for moderate to severe (OSA) as it works as a pneumatic splint of the collapsible airway and it may induce anatomical and functional changes of the upper air way muscles. Treatment with CPAP was reported to decrease daytime sleepiness, and improve the quality of life among sleep apnea patients. However, its impact on other outcomes such as hypertension was modest but clinically significant and it may has no impact on other major cardiovascular outcomes such as cardiovascular mortality, acute coronary syndrome, stroke, transient ischemic attack or hospitalization for heart failure even in patients with established coronary artery disease, and the same result was seen in two recently published meta-analyses.
The widely used definition of acceptable adherence to the CPAP is 4 hours per night for more than 70% of all monitored days or 5 days per week. However, this definition was based on experts' opinion and the knowledge about human sleep. Many studies showed that the 4 hours cut-off was the minimum required amount of time to gain significant improvement from CPAP use and there was a linear dose response relationship with greater benefit observed with increasing nightly use.
However, few studies conducted to assess the effect of CPAP withdrawal following long term treatment of OSAS with conflicting results. The residual effects of CPAP after withdrawal has been controversial in the medical literature. Although some studies suggest that there is some form of reversibility associated with CPAP compliance which leads to improvement in subjective and objective assessment of sleepiness, however, other reports revealed that CPAP withdrawal is associated with a rapid recurrence of OSAS. Rossi et al reported that in 71% of the study population, CPAP withdrawal for four nights was associated with relapse of OSA. However, 10 % remained in remission after 2 weeks of treatment withdrawal. Moreover, we could not find a study that evaluated an intermittent CPAP therapy after a long period of adherence. However, Issa \& Sullivan reported that after 2-3 month of daily CPAP use, patients who use CPAP on intermittent 3-4 nights "on" and 2-3 nights "off were able to maintain good day time function, which maybe a reflection of a less fragmented sleep, thus an adequately controlled OSAS.
Nevertheless, the withdrawal of CPAP raises an ethical concern. However, several reports support the relieve from this fear. Studies of Short-term CPAP withdrawal revealed that it was not associated with any impairment of coronary endothelial function, or raise of stress hormones and markers of vascular inflammation. In addition, the recent Australian and the SAVE studies that were quoted before revealed no significant effect of CPAP on preventing secondary cardiovascular diseases.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Withdrawal of Continuous Positive Airway Pressure device, Alternation usage of Continuous Positive Airway Pressure Device
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withdrawal of Continuous Positive Airway Pressure deviceDevice
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.
Alternation usage of Continuous Positive Airway Pressure DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Obstructive Sleep Apnea | Experimental | Patients whom have an apnea/hypopnea index above fifteen are classified to have moderate obstructive sleep apnea Receives: 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 Receives: Device: Withdrawal of Continuous Positive Airway Pressure device; Device: Alternation usage of Continuous Positive Airway Pressure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving a desaturation SPO2 index of >10 or AHI of >5
Achieving a desaturation SPO2 index of >10 or AHI of >5
Measured: six months
Secondary outcomes (1)
Recurrence of excessive sleepiness daytime symptoms
- lack of concentration
- inability to retain new information
- dozing off or feeling sleepy while driving, sitting or talking
- fogy mind
- feeling sleepy despite long hours of sleeping
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start23 Mar 2020
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siraj Omar Wali, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471765
- Sponsor's protocol ID
- 241-20
- Status last verified
- Jul 2022
- First submitted
- 29 Jun 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40167853
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Positive Airway Pressure Therapy Withdrawal in Patients With Obstructive Sleep Apnea: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05471765
- Acronym / sponsor ID
- 241-20
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- NO CPAP (NOCPAP Group): Who will stop using the CPAP device.
- 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.
Detailed description
Obstructive sleep apnea syndrome (OSAS) is a common sleep-related breathing disorder, which is characterized by transient interruption of ventilation during sleep caused by complete or partial collapse of the upper airway. Many risk factors are identified such as: male gender, large neck circumference, smoking, excessive alcohol intake and high Body Mass Index (BMI).
The prevalence of OSAS in Saudi Arabia is about 4% and 1.8% in males and females, respectively, and it is associated with many comorbidities like type 2 DM, ischemic heart disease, congestive heart failure, hypertension and depression.
Continuous positive airway pressure (CPAP) is considered the gold standard treatment for moderate to severe (OSA) as it works as a pneumatic splint of the collapsible airway and it may induce anatomical and functional changes of the upper air way muscles. Treatment with CPAP was reported to decrease daytime sleepiness, and improve the quality of life among sleep apnea patients. However, its impact on other outcomes such as hypertension was modest but clinically significant and it may has no impact on other major cardiovascular outcomes such as cardiovascular mortality, acute coronary syndrome, stroke, transient ischemic attack or hospitalization for heart failure even in patients with established coronary artery disease, and the same result was seen in two recently published meta-analyses.
The widely used definition of acceptable adherence to the CPAP is 4 hours per night for more than 70% of all monitored days or 5 days per week. However, this definition was based on experts' opinion and the knowledge about human sleep. Many studies showed that the 4 hours cut-off was the minimum required amount of time to gain significant improvement from CPAP use and there was a linear dose response relationship with greater benefit observed with increasing nightly use.
However, few studies conducted to assess the effect of CPAP withdrawal following long term treatment of OSAS with conflicting results. The residual effects of CPAP after withdrawal has been controversial in the medical literature. Although some studies suggest that there is some form of reversibility associated with CPAP compliance which leads to improvement in subjective and objective assessment of sleepiness, however, other reports revealed that CPAP withdrawal is associated with a rapid recurrence of OSAS. Rossi et al reported that in 71% of the study population, CPAP withdrawal for four nights was associated with relapse of OSA. However, 10 % remained in remission after 2 weeks of treatment withdrawal. Moreover, we could not find a study that evaluated an intermittent CPAP therapy after a long period of adherence. However, Issa \& Sullivan reported that after 2-3 month of daily CPAP use, patients who use CPAP on intermittent 3-4 nights "on" and 2-3 nights "off were able to maintain good day time function, which maybe a reflection of a less fragmented sleep, thus an adequately controlled OSAS.
Nevertheless, the withdrawal of CPAP raises an ethical concern. However, several reports support the relieve from this fear. Studies of Short-term CPAP withdrawal revealed that it was not associated with any impairment of coronary endothelial function, or raise of stress hormones and markers of vascular inflammation. In addition, the recent Australian and the SAVE studies that were quoted before revealed no significant effect of CPAP on preventing secondary cardiovascular diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Obstructive Sleep Apnea | Experimental | Device: Withdrawal of Continuous Positive Airway Pressure device, Device: Alternation usage of Continuous Positive Airway Pressure DevicePatients whom have an apnea/hypopnea index above fifteen are classified to have moderate obstructive sleep apnea |
| Severe Obstructive Sleep Apnea | Experimental | Device: Withdrawal of Continuous Positive Airway Pressure device, Device: Alternation usage of Continuous Positive Airway Pressure DevicePatients whom have an apnea/hypopnea index with a result higher than thirty are considered to have severe obstructive sleep apnea |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Withdrawal of Continuous Positive Airway Pressure deviceAfter 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 | Moderate Obstructive Sleep Apnea, Severe Obstructive Sleep Apnea |
| Alternation usage of Continuous Positive Airway Pressure DeviceAfter 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. | Device | Moderate Obstructive Sleep Apnea, Severe Obstructive Sleep Apnea |
Primary outcome
Achieving a desaturation SPO2 index of >10 or AHI of >5
Time frame: six months
Achieving a desaturation SPO2 index of >10 or AHI of >5
1 secondary outcome
Recurrence of excessive sleepiness daytime symptoms
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Derived from this study: PubMed 40167853Wali 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Withdrawal of Continuous Positive Airway Pressure device and Alternation usage of Continuous Positive Airway Pressure Device in people with Obstructive Sleep Apnea, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siraj O Wali, Professor (0126408222 ext. 16045, sowali@kau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieving a desaturation SPO2 index of >10 or AHI of >5 (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05471765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.