OSA Recurrence in CPAP Withdrawal

NCT03472612 | Completed

• 1 other identifier: 237921
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

OSA

Keywords

OSA; CPAP; upper airway collapse; neural respiratory drive

Outcome Measures

Primary Outcomes (1)

• Change in neural respiratory drive (NRD) during sleep upon CPAP therapy withdrawal

  Electromyography of respiratory muscles as measure of neural respiratory drive

  2 weeks

Secondary Outcomes (15)

• Pharyngeal critical occlusion pressure during sleep (Pcrit)

  2 weeks

• Forced oscillation technique (FOT)

  2 weeks

• Negative expiratory pressure (NEP)

  2 weeks

• Pharyngeal oedema

  2 weeks

• Forced expiratory volume in 1 second

  2 weeks

Other Outcomes (1)

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

  2 weeks

Study Arms (1)

CPAP withdrawal

EXPERIMENTAL

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

Other: CPAP withdrawal

Interventions

CPAP withdrawal OTHER

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

CPAP withdrawal

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guys and St Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Study Officials

• Joerg Steier, MD Ph

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 21, 2018
• Study Start: April 9, 2018
• Primary Completion: June 30, 2019
• Study Completion: October 1, 2019
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)