OSANCT03472612
OSA Recurrence in CPAP Withdrawal
A study testing CPAP withdrawal in people with OSA, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Continuous positive airway pressure (CPAP) therapy is the most effective Treatment for obstructive sleep apnoea (OSA ). However, adherence to CPAP is often limited. There are established and emerging treatment alternatives to CPAP available, however, they are usually less effective than CPAP. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- OSA
- What is being tested?
- CPAP withdrawal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Apr 2018to 1 Oct 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18-80 years. Objectively confirmed OSA with an apnoea-hypopnoea- index (AHI) or an oxygen desaturation index (ODI) of ≥20/h at the time of diagnosis (obstructive events).
- Effectively treated with CPAP for > 6 months (AHI on CPAP < 5/h, CPAP usage > 4 hours/night > 70% of the days).
Who cannot join
- Moderate to severe obstructive (FEV1/FVC < lower limit of normal and FEV1 < 70% predicted) or restrictive lung disease (FVC < 60% predicted).
- Daytime pCO2 > 6 kPa (45 mmHg).
- Central Sleep Apnoea/Cheyne Stokes Respiration. Unstable heart failure, untreated coronary artery disease, severe arterial hypertension (resting blood pressure >180/110 mmHg).
- Co-existing non-respiratory sleep disorder (by history).
- Opioid or sedative use. Alcohol abuse.
- Current professional driver or comparable profession.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guys and St Thomas NHS Foundation Trust
London, SE1 7EH
About this study
Official title: Pathophysiology of Obstructive Sleep Apnoea Recurrence During Continuous Positive Airway Pressure Therapy Withdrawal
Continuous positive airway pressure (CPAP) therapy is the most effective Treatment for obstructive sleep apnoea (OSA ). However, adherence to CPAP is often limited. There are established and emerging treatment alternatives to CPAP available, however, they are usually less effective than CPAP. To develop novel treatment methods and to predict who will respond to which treatment, the mechanism underlying obstructive sleep apnoea and different patient types should be described. Especially the contribution of the upper airway function and central respiratory control should be studied for this purpose. In a prospective interventional study, patients with OSA effectively treated with CPAP will undergo physiologic measurements during a two week period off CPAP to define the pathophysiological mechanisms associated with OSA recurrence. This knowledge could facilitate individually tailored treatment and improve therapy adherence and patient outcomes.
Read the detailed description
Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder characterised by a repetitive collapse of the pharynx during sleep, which results in apnoea or hypopnoea associated with oxygen desaturations and arousal from sleep. Continuous positive airway pressure (CPAP) is the gold standard treatment. Treatment success depends on regular CPAP usage. However, low adherence to CPAP is a frequent problem. It has recently been shown that OSA does not re-occur immediately in all OSA patients upon CPAP therapy withdrawal and that there are different patterns of recurrence of OSA as indicated by repeated sleep studies. So far, the mechanisms of OSA recurrence upon CPAP therapy withdrawal are incompletely understood. Upper airway collapsibility and neuromuscular tone, pharyngeal oedema and inflammation, neural respiratory drive, sleep stage and position may play a role.
In a prospective interventional study, patients with OSA effectively treated with CPAP will undergo physiologic measurements during a two week period off CPAP to define the pathophysiological mechanisms associated with OSA recurrence. In particular, we will investigate the effects of CPAP withdrawal on neural respiratory drive and upper airway function. Inpatient sleep studies and assessments will be performed at baseline (day 0) on CPAP and at follow-up upon CPAP withdrawal (day 14). At the end of the trial patients will return to their established CPAP therapy.
We hypothesise that CPAP withdrawal results in different patterns of OSA recurrence defined by neural respiratory drive and upper airway function. The aim of the proposed project is to study the mechanisms of OSA recurrence by using a validated CPAP withdrawal model. Knowledge on recurrence patterns and different phenotypes of OSA could facilitate individually tailored treatment of OSA and improved therapy adherence and patient outcomes.
- Conditions
- OSA
- Being tested
- CPAP withdrawal
- Keywords
- OSA, CPAP, upper airway collapse, neural respiratory drive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP withdrawalOther
Short-term withdrawal of CPAP therapy in moderate to severe OSA
| Study group | Role | What they receive |
|---|---|---|
| CPAP withdrawal | Experimental | Short-term withdrawal of CPAP therapy in moderate to severe OSA (intervention) Receives: Other: CPAP withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neural respiratory drive (NRD) during sleep upon CPAP therapy withdrawal
Electromyography of respiratory muscles as measure of neural respiratory drive
Measured: 2 weeks
Secondary outcomes (15)
Pharyngeal critical occlusion pressure during sleep (Pcrit)
Measures of upper airway collapsibility (cmH2O)
Measured: 2 weeks
Forced oscillation technique (FOT)
Measure of (upper) airway resistance
Measured: 2 weeks
Negative expiratory pressure (NEP)
Measure of (upper) airway resistance and collapsibility (cmH2O)
Measured: 2 weeks
Pharyngeal oedema
Transcervical ultrasound (mm)
Measured: 2 weeks
Forced expiratory volume in 1 second
Spirometry
Measured: 2 weeks
Forced vital capacity
Spirometry
Measured: 2 weeks
Recurrence pattern of OSA defined by the nightly obstructive respiratory events (apnoea-hypopnoea-index)
Polysomnography (events/hour)
Measured: 2 weeks
Recurrence pattern of OSA defined by the nightly obstructive respiratory events (oxygen desaturation index)
Nightly home pulse oximetry (events/hour)
Measured: 2 weeks
Home and office blood pressure
Blood pressure (mmHg)
Measured: 2 weeks
Home and office heart rate
Heart rate (bpm)
Measured: 2 weeks
Epworth Sleepiness Scale Score (ESS)
Questionnaire for subjective sleepiness (Points)
Measured: 2 weeks
Fatigue Severity Sclae (FSS)
Questionnaire for subjective sleepiness (Points)
Measured: 2 weeks
Stanford Sleepiness Scale (SSS)
Questionnaire for subjective sleepiness (Points)
Measured: 2 weeks
Functional Outcomes of Sleep Questionnaire (FOSQ)
Quality of life questionnaire
Measured: 2 weeks
Association between ODI (recurrence pattern of OSA) and neural respiratory drive (NRD)
Multivariate Regression modelling with ODI as dependent variable
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start9 Apr 2018
- Primary completion30 Jun 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joerg Steier, MD Ph, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472612
- Sponsor's protocol ID
- 237921
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2018
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology of Obstructive Sleep Apnoea Recurrence During Continuous Positive Airway Pressure Therapy Withdrawal
- ClinicalTrials.gov ID
- NCT03472612
- Acronym / sponsor ID
- 237921
- Conditions
- OSA
- Keywords
- OSA, CPAP, upper airway collapse, neural respiratory drive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 21 Mar 2018 (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.
Continuous positive airway pressure (CPAP) therapy is the most effective Treatment for obstructive sleep apnoea (OSA ). However, adherence to CPAP is often limited. There are established and emerging treatment alternatives to CPAP available, however, they are usually less effective than CPAP. To develop novel treatment methods and to predict who will respond to which treatment, the mechanism underlying obstructive sleep apnoea and different patient types should be described. Especially the contribution of the upper airway function and central respiratory control should be studied for this purpose. In a prospective interventional study, patients with OSA effectively treated with CPAP will undergo physiologic measurements during a two week period off CPAP to define the pathophysiological mechanisms associated with OSA recurrence. This knowledge could facilitate individually tailored treatment and improve therapy adherence and patient outcomes.
Detailed description
Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder characterised by a repetitive collapse of the pharynx during sleep, which results in apnoea or hypopnoea associated with oxygen desaturations and arousal from sleep. Continuous positive airway pressure (CPAP) is the gold standard treatment. Treatment success depends on regular CPAP usage. However, low adherence to CPAP is a frequent problem. It has recently been shown that OSA does not re-occur immediately in all OSA patients upon CPAP therapy withdrawal and that there are different patterns of recurrence of OSA as indicated by repeated sleep studies. So far, the mechanisms of OSA recurrence upon CPAP therapy withdrawal are incompletely understood. Upper airway collapsibility and neuromuscular tone, pharyngeal oedema and inflammation, neural respiratory drive, sleep stage and position may play a role.
In a prospective interventional study, patients with OSA effectively treated with CPAP will undergo physiologic measurements during a two week period off CPAP to define the pathophysiological mechanisms associated with OSA recurrence. In particular, we will investigate the effects of CPAP withdrawal on neural respiratory drive and upper airway function. Inpatient sleep studies and assessments will be performed at baseline (day 0) on CPAP and at follow-up upon CPAP withdrawal (day 14). At the end of the trial patients will return to their established CPAP therapy.
We hypothesise that CPAP withdrawal results in different patterns of OSA recurrence defined by neural respiratory drive and upper airway function. The aim of the proposed project is to study the mechanisms of OSA recurrence by using a validated CPAP withdrawal model. Knowledge on recurrence patterns and different phenotypes of OSA could facilitate individually tailored treatment of OSA and improved therapy adherence and patient outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP withdrawal | Experimental | Other: CPAP withdrawalShort-term withdrawal of CPAP therapy in moderate to severe OSA (intervention) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18-80 years. Objectively confirmed OSA with an apnoea-hypopnoea- index (AHI) or an oxygen desaturation index (ODI) of ≥20/h at the time of diagnosis (obstructive events).
- Effectively treated with CPAP for > 6 months (AHI on CPAP < 5/h, CPAP usage > 4 hours/night > 70% of the days).
Key exclusion criteria (6 listed)
- Moderate to severe obstructive (FEV1/FVC < lower limit of normal and FEV1 < 70% predicted) or restrictive lung disease (FVC < 60% predicted).
- Daytime pCO2 > 6 kPa (45 mmHg).
- Central Sleep Apnoea/Cheyne Stokes Respiration. Unstable heart failure, untreated coronary artery disease, severe arterial hypertension (resting blood pressure >180/110 mmHg).
- Co-existing non-respiratory sleep disorder (by history).
- Opioid or sedative use. Alcohol abuse.
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 |
|---|---|---|
| CPAP withdrawalShort-term withdrawal of CPAP therapy in moderate to severe OSA | Other | CPAP withdrawal |
Primary outcome
Change in neural respiratory drive (NRD) during sleep upon CPAP therapy withdrawal
Time frame: 2 weeks
Electromyography of respiratory muscles as measure of neural respiratory drive
15 secondary outcomes
Pharyngeal critical occlusion pressure during sleep (Pcrit)
Time frame: 2 weeks
Forced oscillation technique (FOT)
Time frame: 2 weeks
Negative expiratory pressure (NEP)
Time frame: 2 weeks
Pharyngeal oedema
Time frame: 2 weeks
Forced expiratory volume in 1 second
Time frame: 2 weeks
Forced vital capacity
Time frame: 2 weeks
Recurrence pattern of OSA defined by the nightly obstructive respiratory events (apnoea-hypopnoea-index)
Time frame: 2 weeks
Recurrence pattern of OSA defined by the nightly obstructive respiratory events (oxygen desaturation index)
Time frame: 2 weeks
Home and office blood pressure
Time frame: 2 weeks
Home and office heart rate
Time frame: 2 weeks
Epworth Sleepiness Scale Score (ESS)
Time frame: 2 weeks
Fatigue Severity Sclae (FSS)
Time frame: 2 weeks
Stanford Sleepiness Scale (SSS)
Time frame: 2 weeks
Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: 2 weeks
Association between ODI (recurrence pattern of OSA) and neural respiratory drive (NRD)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- 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.
Joerg Steier, MD Ph principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP withdrawal in people with OSA, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 15 Mar 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neural respiratory drive (NRD) during sleep upon CPAP therapy withdrawal (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2022; AzTrials last refreshed its copy on 2 Nov 2026.