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Completed

NCT Number: NCT03472612

OSA Recurrence in CPAP 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.

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Key information

Conditions

OSA

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guys and St Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPAP withdrawal

Other

Short-term withdrawal of CPAP therapy in moderate to severe OSA

Primary outcomes

  1. 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

Secondary outcomes

  1. Pharyngeal critical occlusion pressure during sleep (Pcrit)

    Time frame: 2 weeks

    Measures of upper airway collapsibility (cmH2O)

  2. Forced oscillation technique (FOT)

    Time frame: 2 weeks

    Measure of (upper) airway resistance

  3. Negative expiratory pressure (NEP)

    Time frame: 2 weeks

    Measure of (upper) airway resistance and collapsibility (cmH2O)

  4. Pharyngeal oedema

    Time frame: 2 weeks

    Transcervical ultrasound (mm)

  5. Forced expiratory volume in 1 second

    Time frame: 2 weeks

    Spirometry

  6. Forced vital capacity

    Time frame: 2 weeks

    Spirometry

  7. Recurrence pattern of OSA defined by the nightly obstructive respiratory events (apnoea-hypopnoea-index)

    Time frame: 2 weeks

    Polysomnography (events/hour)

  8. Recurrence pattern of OSA defined by the nightly obstructive respiratory events (oxygen desaturation index)

    Time frame: 2 weeks

    Nightly home pulse oximetry (events/hour)

  9. Home and office blood pressure

    Time frame: 2 weeks

    Blood pressure (mmHg)

  10. Home and office heart rate

    Time frame: 2 weeks

    Heart rate (bpm)

  11. Epworth Sleepiness Scale Score (ESS)

    Time frame: 2 weeks

    Questionnaire for subjective sleepiness (Points)

  12. Fatigue Severity Sclae (FSS)

    Time frame: 2 weeks

    Questionnaire for subjective sleepiness (Points)

  13. Stanford Sleepiness Scale (SSS)

    Time frame: 2 weeks

    Questionnaire for subjective sleepiness (Points)

  14. Functional Outcomes of Sleep Questionnaire (FOSQ)

    Time frame: 2 weeks

    Quality of life questionnaire

  15. Association between ODI (recurrence pattern of OSA) and neural respiratory drive (NRD)

    Time frame: 2 weeks

    Multivariate Regression modelling with ODI as dependent variable

Other outcomes

  1. Association between different measures of (upper) airway function, namely Pcrit, FOT, NEP and FEV1/FVC

    Time frame: 2 weeks

    Correlation analyses

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study title

Pathophysiology of Obstructive Sleep Apnoea Recurrence During Continuous Positive Airway Pressure Therapy Withdrawal

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2018
Registry last updated
Mar 15, 2022

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.

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