Comparison of CPAP Modalities for OSA Treatment

Associação Fundo de Incentivo à Pesquisa

Status: Unknown

Conditions: Obstructive Sleep Apnea

Treatments: Device: CPAP Fixed Pressure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03212209

AssociacaoFIP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 3 patient groups

CPAP C- Flex-Plus by Philips Respironics

Experimental group

Description:

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.

Treatment:

Device: CPAP Fixed Pressure

CPAP with Sensawake by Fisher and Paykel

Experimental group

Description:

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.

Treatment:

Device: CPAP Fixed Pressure

CPAP fixed pressure

Active Comparator group

Description:

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.

Treatment:

Device: CPAP Fixed Pressure