Acute and Long-term Effects of CPAP in OSA

NCT06277115 | Completed

• 1 other identifier: BASEC Nr. 2020-02002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Two-phase interventional non-inferiority trial (phase 1: at least 8 weeks of CPAP; phase 2: 2 weeks of CPAP withdrawal) including 32 patients with moderate to severe OSA to compare the physiological consequences of a short-term CPAP withdrawal to the changes in previously untreated OSA. The trial has been designed as a validation of the CPAP-withdrawal model. Baseline in-laboratory sleep studies will be performed prior to CPAP initiation, after 6-8 weeks on CPAP (treatment effect) and following 2 weeks of CPAP therapy withdrawal (withdrawal effect, effect of OSA recurrence).

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (2)

• Nocturnal systolic blood pressure

  Ambulatory blood pressure monitoring (ABPM)

  at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal

• Epworth Sleepines Scale Score (ESS)

  Subjective sleepiness, ESS min-max 0-24 points and ESS \>10 indicating pathological daytime sleepiness

  at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal

Secondary Outcomes (20)

• 48h, 24h, diurnal and nocturnal systolic and diastolic blood pressure

  at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal

• Office systolic and diastolic blood pressure

  at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal

• 48h, 24h, diurnal, nocturnal and office heart rate

  at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal

• Heart rate variability in the time and frequency domain (CV, RMSSD, pRR50, LF, HF, LF/HF)

  at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal

• Blood pressure variability (BPV, systolic and diastolic)

  at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal

Study Arms (1)

Single arm (therapy initiation followed by therapy withdrawal)

OTHER

Continuous positive airway pressure (CPAP)

Device: Continuous positive airway pressure (CPAP)

Interventions

Continuous positive airway pressure (CPAP) DEVICE

Nocturnal continuous positive airway pressure therapy is the gold standard treatment for symptomatic OSA. It provides positive pressure via a nasal or oronasal mask to prevent upper airway collapse during sleep.

Single arm (therapy initiation followed by therapy withdrawal)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Untreated moderate or severe OSA with an apnoea-hypopnoea-index (AHI) of ≥ 20/h and an oxygen desaturation index (\>3%-dips) of ≥ 20/h in an in-laboratory sleep study
• Epworth Sleepiness Scale Score ≥7/24 points
• Indication for CPAP therapy
• Written informed consent

You may not qualify if:

• Moderate or more severe obstructive or restrictive ventilatory disorder (FEV1 or FVC \< 70%)
• Heart failure
• Other types of sleep-related breathing disorders, e.g. sleep-associated hypoventilation, central sleep apnoea, Cheyne Stoke's Breathing
• Hypoxic or hypercapnic respiratory failure (awake paO2 \< 9 kPa or paCO2 \> 6 kPa)
• Active treatment for OSA (CPAP, mandibular advancement device, hypoglossal nerve stimulation)
• Current professional driver or previous sleepiness-related accidents
• Pregnancy

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Esther I Schwarz, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Clinical Director Department of Pulmonology, Principal Investigator

Model Details: Two-phase intervention: several weeks of CPAP therapy followed by two weeks CPAP therapy withdrawal

Study Record Dates

• First Submitted: February 10, 2024
• First Posted: February 26, 2024
• Study Start: February 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

CH (1)