Comparison of CPAP Modalities for OSA Treatment

NCT ID: NCT03212209

Last Updated: 2017-12-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-28
• Study Completion Date: 2018-07-16

Brief Summary

This is a crossover study comparing the effect of CPAP Fixed Pressure, CPAP FLEX -PLUS and Sensawake on sleep quality, adherence to treatments, and PSG parameters in patients with moderate to severe OSA.

Detailed Description

Obstructive sleep apnea (OSA) is associated with behavioral, cognitive, metabolic and cardiovascular conditions. Continuous Positive Airway Pressure (CPAP) is the gold standard treatment for OSA. Despite being the most effective treatment for OSA, 46 to 83% of patients do not adhere to CPAP. New technologies for CPAP treatment have been developed in order to improve patient's comfort, adherence and effectiveness in reducing apnea, hypopneas and flow limitation events. As an example, the FLEX- PLUS technology which increases inspiratory positive pressure and decreases expiratory positive pressure would soften the rhythm of breathing. Sensawake is another technology which evaluates breathing pattern changes during CPAP therapy. When the breathing pattern suggests that patient is awake, a prompt relief in pressure is activated, like ramp feature. However, it is not clear whether CPAP FLEX- PLUS or Sensawake are superior compared with fixed pressure CPAP, in terms of polysomnographic parameters, especially flow limitation or adherence to treatment. Objective: To compare the effect of fixed pressure CPAP, CPAP FLEX- PLUS and Sensawake on sleep and compliance parameters in patients with moderate to severe OSA. Methods: Fifty male patients with moderate to severe OSA will be included in a crossover design study. All patients will use each CPAP modality for 30 days in a randomized order, namely CPAP with Fixed Pressure, Flex- PLUS and Sensawake. A week of washout period will be applied between treatments. All patients will wear the same nasal mask brand. At the end of each treatment (every 4 weeks), patients will undergo polysomnography and fill out Epworth, FOSQ, Pittsburgh questionnaires and a visual analogue scale assessing CPAP side effects and patient´s comfort. Finally, adherence to CPAP modalities will be systematically checked.

Conditions

Obstructive Sleep Apnea

Keywords

Sleep Apnea; CPAP

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CPAP C- Flex-Plus by Philips Respironics

Four consecutive weeks with CPAP C- FLEX PLUS treatment. After these 4 weeks, patients will undergo full PSG with CPAP FLEX- PLUS. Patients will also fill out Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcome Sleep Questionnaire, and visual analogue scale assessing CPAP side effects and patient´s comfort. Adherence to 4-week treatment will be checked. Treatment is followed by 7-day washout period.

Group Type: EXPERIMENTAL

CPAP Fixed Pressure

Intervention Type: DEVICE

Continuous positive airway pressure (CPAP) is the gold standard treatment for moderate and severe OSA, and it has been known to apply positive pressure in the upper airways, acting as a pneumatic splint preventing the upper airway collapse during sleep. CPAP C- Flex Plus by Philips - Respironics works just as CPAP Fixed Pressure, but increases the pressure delivered in the begining of inhalation to softens the breathing rhythm of the CPAP user. CPAP with SensAwake by Fisher and Paykel works just as CPAP fixed pressure but when the breathing pattern suggests that patient is awake, a prompt relief in pressure to the lowest most comfortable level is activated, like ramp feature.

CPAP with Sensawake by Fisher and Paykel

Four consecutive weeks with CPAP Sensawake treatment. After these 4 weeks, patients will undergo full PSG with the same CPAP modality. Patients will also fill out Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcome Sleep Questionnaire, and visual analogue scale assessing CPAP side effects and patient´s comfort. Adherence to 4-week treatment will be checked. Treatment is followed by 7-day washout period.

Group Type: EXPERIMENTAL

CPAP Fixed Pressure

Intervention Type: DEVICE

Continuous positive airway pressure (CPAP) is the gold standard treatment for moderate and severe OSA, and it has been known to apply positive pressure in the upper airways, acting as a pneumatic splint preventing the upper airway collapse during sleep. CPAP C- Flex Plus by Philips - Respironics works just as CPAP Fixed Pressure, but increases the pressure delivered in the begining of inhalation to softens the breathing rhythm of the CPAP user. CPAP with SensAwake by Fisher and Paykel works just as CPAP fixed pressure but when the breathing pattern suggests that patient is awake, a prompt relief in pressure to the lowest most comfortable level is activated, like ramp feature.

CPAP fixed pressure

Four consecutive weeks with CPAP fixed pressure treatment. After these 4 weeks, patients will undergo full PSG with the same CPAP modality. Patients will also fill out Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcome Sleep Questionnaire, and visual analogue scale assessing CPAP side effects and patient´s comfort. Adherence to 4-week treatment will be checked. Treatment is followed by 7-day washout period.

Group Type: ACTIVE_COMPARATOR

CPAP Fixed Pressure

Intervention Type: DEVICE

Continuous positive airway pressure (CPAP) is the gold standard treatment for moderate and severe OSA, and it has been known to apply positive pressure in the upper airways, acting as a pneumatic splint preventing the upper airway collapse during sleep. CPAP C- Flex Plus by Philips - Respironics works just as CPAP Fixed Pressure, but increases the pressure delivered in the begining of inhalation to softens the breathing rhythm of the CPAP user. CPAP with SensAwake by Fisher and Paykel works just as CPAP fixed pressure but when the breathing pattern suggests that patient is awake, a prompt relief in pressure to the lowest most comfortable level is activated, like ramp feature.

Interventions

CPAP Fixed Pressure

Continuous positive airway pressure (CPAP) is the gold standard treatment for moderate and severe OSA, and it has been known to apply positive pressure in the upper airways, acting as a pneumatic splint preventing the upper airway collapse during sleep. CPAP C- Flex Plus by Philips - Respironics works just as CPAP Fixed Pressure, but increases the pressure delivered in the begining of inhalation to softens the breathing rhythm of the CPAP user. CPAP with SensAwake by Fisher and Paykel works just as CPAP fixed pressure but when the breathing pattern suggests that patient is awake, a prompt relief in pressure to the lowest most comfortable level is activated, like ramp feature.

Intervention Type: DEVICE

Other Intervention Names

CPAP C- Flex Plus by Philips Respironics; CPAP with SensAwake by Fisher and Paykel

Eligibility Criteria

Inclusion Criteria

• male gender
• apnea-hypopnea index (AHI) score of ≥20 events/hour of sleep
• 30-65 years-old
• body mass index (BMI) ≤40 Kg/m²

Exclusion Criteria

• major neurological, psychiatric, cardiac or respiratory disease
• use of psychoactive medication
• other sleep disorders
• patients referred to PSG for Bilevel, considered the need for PAP ≥ 18 cm H2O
• Previous contact with any OSA treatment.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: collaborator

Philips Respironics

INDUSTRY

Sponsor Role: collaborator

Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role: lead

Responsible Party

Dalva Poyares

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dalva Poyares, MD, PhD

Role: STUDY_DIRECTOR

AFIP - Associação de fundo e incentivo a pesquisa

Locations

Evelyn Brasil

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Evelyn Brasil, Pt

Role: primary

Dalva Poyares, MD,PhD

Role: backup

Other Identifiers

AssociacaoFIP

Identifier Type: -

Identifier Source: org_study_id