Guys and St Thomas NHS Foundation Trust
London, SE1 7EH, United Kingdom
NCT Number: NCT03472612
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
London, SE1 7EH, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Short-term withdrawal of CPAP therapy in moderate to severe OSA
Time frame: 2 weeks
Electromyography of respiratory muscles as measure of neural respiratory drive
Time frame: 2 weeks
Measures of upper airway collapsibility (cmH2O)
Time frame: 2 weeks
Measure of (upper) airway resistance
Time frame: 2 weeks
Measure of (upper) airway resistance and collapsibility (cmH2O)
Time frame: 2 weeks
Transcervical ultrasound (mm)
Time frame: 2 weeks
Spirometry
Time frame: 2 weeks
Spirometry
Time frame: 2 weeks
Polysomnography (events/hour)
Time frame: 2 weeks
Nightly home pulse oximetry (events/hour)
Time frame: 2 weeks
Blood pressure (mmHg)
Time frame: 2 weeks
Heart rate (bpm)
Time frame: 2 weeks
Questionnaire for subjective sleepiness (Points)
Time frame: 2 weeks
Questionnaire for subjective sleepiness (Points)
Time frame: 2 weeks
Questionnaire for subjective sleepiness (Points)
Time frame: 2 weeks
Quality of life questionnaire
Time frame: 2 weeks
Multivariate Regression modelling with ODI as dependent variable
Time frame: 2 weeks
Correlation analyses
Guy's and St Thomas' NHS Foundation Trust
Other
Pathophysiology of Obstructive Sleep Apnoea Recurrence During Continuous Positive Airway Pressure Therapy Withdrawal
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04950894
Apnea, Apnea+Hypopnea
Birmingham, Alabama, United States
View Trial DetailsNCT06540716
Apnea, Dyssomnias
Singapore
View Trial DetailsNCT05977296
Apnea, CPAP
Tainan, Taiwan
View Trial DetailsNCT05094271
Alzheimer Disease, Apnea
La Jolla, California, United States
View Trial Details