- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03472612
OSA Recurrence in CPAP Withdrawal
Pathophysiology of Obstructive Sleep Apnoea Recurrence During Continuous Positive Airway Pressure Therapy Withdrawal
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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London, United Kingdom, SE1 7EH
- Guys and St Thomas Nhs Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- 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).
Exclusion criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CPAP withdrawal
Short-term withdrawal of CPAP therapy in moderate to severe OSA (intervention)
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Short-term withdrawal of CPAP therapy in moderate to severe OSA
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharyngeal critical occlusion pressure during sleep (Pcrit)
Time Frame: 2 weeks
|
Measures of upper airway collapsibility (cmH2O)
|
2 weeks
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Forced oscillation technique (FOT)
Time Frame: 2 weeks
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Measure of (upper) airway resistance
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2 weeks
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Negative expiratory pressure (NEP)
Time Frame: 2 weeks
|
Measure of (upper) airway resistance and collapsibility (cmH2O)
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2 weeks
|
Pharyngeal oedema
Time Frame: 2 weeks
|
Transcervical ultrasound (mm)
|
2 weeks
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Forced expiratory volume in 1 second
Time Frame: 2 weeks
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Spirometry
|
2 weeks
|
Forced vital capacity
Time Frame: 2 weeks
|
Spirometry
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2 weeks
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Recurrence pattern of OSA defined by the nightly obstructive respiratory events (apnoea-hypopnoea-index)
Time Frame: 2 weeks
|
Polysomnography (events/hour)
|
2 weeks
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Recurrence pattern of OSA defined by the nightly obstructive respiratory events (oxygen desaturation index)
Time Frame: 2 weeks
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Nightly home pulse oximetry (events/hour)
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2 weeks
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Home and office blood pressure
Time Frame: 2 weeks
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Blood pressure (mmHg)
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2 weeks
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Home and office heart rate
Time Frame: 2 weeks
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Heart rate (bpm)
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2 weeks
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Epworth Sleepiness Scale Score (ESS)
Time Frame: 2 weeks
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Questionnaire for subjective sleepiness (Points)
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2 weeks
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Fatigue Severity Sclae (FSS)
Time Frame: 2 weeks
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Questionnaire for subjective sleepiness (Points)
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2 weeks
|
Stanford Sleepiness Scale (SSS)
Time Frame: 2 weeks
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Questionnaire for subjective sleepiness (Points)
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2 weeks
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Functional Outcomes of Sleep Questionnaire (FOSQ)
Time Frame: 2 weeks
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Quality of life questionnaire
|
2 weeks
|
Association between ODI (recurrence pattern of OSA) and neural respiratory drive (NRD)
Time Frame: 2 weeks
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Multivariate Regression modelling with ODI as dependent variable
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2 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between different measures of (upper) airway function, namely Pcrit, FOT, NEP and FEV1/FVC
Time Frame: 2 weeks
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Correlation analyses
|
2 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Joerg Steier, MD Ph, Guy's and St Thomas' NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 237921
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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