Obstructive Sleep Apnea Treatment With CPAP With and Without the Use of Expiratory Pressure Relief Technology

NCT05219591 | Unknown DMC

• 1 other identifier: expiratoryrelief
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Expiratory pressure relief (EPR) is a technology designed to improve patient comfort during continous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA). The investigators hypothesized that the use of CPAP with EPR is less effective in controlling OSA when compared to CPAP without EPR, applied at the same treatment pressure. The investigators also hypothesized that the CPAP pressure necessary to abolish respiratory events during both manual and automatic CPAP titration with EPR will be greater than the pressure titrated with CPAP without EPR. OSA participants will undergo full polysomnography during CPAP and EPR will be turned on and off in order to test the impact of EPR on airflow and residual AHI.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (4)

• Peak Inspiratory Flow

  The value of the peak inspiratory flow, measured before and after the activation of expiratory pressure relief technology, on a flow limitation period of sleep

  1 day

• Titrated CPAP level

  The titrated CPAP level with and without the application of expiratory pressure relief technology

  1 day

• Apnea and Hypopnea Index with CPAP on fixed mode

  The index of apnea and hypopnea measured with and without the expiratory pressure relief, measured with the titrated CPAP level, on fixed mode

  15 days, 5 days each group

• Apnea and Hypopnea Index with CPAP on automatic mode

  The index of apnea and hypopnea measured with and without the expiratory pressure relief, with the titrated CPAP level, on automatic mode

  14 days, 7 days each group

Secondary Outcomes (5)

• CPAP mask pressure

  1 day

• CPAP Leakage, with CPAP on fixed mode

  15 days, 5 days each group

• CPAP Leakage, with CPAP on automatic mode

  14 days, 7 days each group

• CPAP usage, with CPAP on fixed mode

  15 days, 5 days each group

• CPAP usage, with CPAP on automatic mode

  15 days, 5 days each group

Study Arms (2)

Polysomnographic night

OTHER

intermittent application of the EPR technology on CPAP device during step 2, on polysomnographic night of the study.

Device: EPR

Outpatient CPAP use

OTHER

Application of EPR technology during outpatient CPAP usage, on steps 3 and 4 of the study

Device: EPR

Interventions

EPR DEVICE

application of EPR technology during CPAP treatment

Outpatient CPAP use; Polysomnographic night

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• both sexes
• aged eighteen or over
• already have baseline polysomnography showing a severe Apnea-Hypopnea Index (AIH), defined according to the current criteria of the American Academy of Sleep Medicine (AASM) as 30 events / hour of sleep or more
• already be using a continuous positive pressure device (CPAP) at a pressure equal to or greater than 9 cmH2O with good adherence, defined as an average use equal to or greater than 4 hours per day.

You may not qualify if:

• Patients with:
• severe or decompensated respiratory or cardiac diseases
• previous pharyngeal surgery or other sleep disorders, such as parasomnias, narcolepsy or primary insomnia
• users of sedative medications such as opioids, benzodiazepines and muscle relaxants
• uncontrolled diabetes or hyperthyroidism

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo

São Paulo, 55, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant Masking: on steps 2, 3 and 4 Investigator Masking: on step 2
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be carried out in 4 steps: 1. During Polysomnography exam: Intermittent application of expiratory pressure relief (EPR), when the peak inspiratory flow will be measured with and without the application of EPR, on sleep stage called N2 2. During Polysomnography exam: After the intermittent application of EPR, manual CPAP pressure titration will be performed with (CPAP-EPRon) and without EPR on (CPAP-EPRoff), under random order and a blinded observer. 3. Use of outpatient CPAP, in random order, for a total of 3 weeks: i. adjusted to the previously titrated pressure CPAP-EPRoff, without the addition of EPR technology (1 week) and with the addition of EPR technology(1 week). ii. adjusted to the previously titrated pressure CPAP-EPRon, with the addition of EPR technology, for 1 week. 4. Use of outpatient CPAP, in random order, for a total of 2 weeks: i. adjusted in automatic mode with adding EPR technology on (1 week) and off (1 week).

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: February 2, 2022
• Study Start: January 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-01

Locations

BR (1)