Trial Outcomes & Findings for Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea (NCT NCT02387476)

Results Overview

The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. Difference of AHI values between patients who used the FRESCA treatment first versus the CPAP treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

per hour

Results posted on

2018-04-24

Participant Flow

Eleven (11) subjects were not included in the primary analysis due to incomplete data on at least one PSG nights. mITT Group (subjects completing 2 nights on study with a Valid PSG result) n=36 See section 8.1 of Clinical Study Report (TR 1000-01) for details.

Participant milestones

Participant milestones
Measure	FRESCA Mask First - CPAP Second First night using FRESCA nasal mask and second night using CPAP FRESCA Nasal Mask: FRESCA nasal mask	CPAP Mask - FRESCA Mask Second One night using CPAP nasal mask and then second night using FRESCA nasal mask CPAP Nasal Mask: CPAP nasal pillow and nasal mask
Overall Study STARTED	25	22
Overall Study COMPLETED	19	17
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FRESCA Mask First CPAP Mask Second n=19 Participants One night using FRESCA nasal mask and the second night using patient provided CPAP	CPAP Mask First and CPAP Mask Second n=17 Participants One night using patient providing CPAP nasal mask and second night using FRESCA mask	Total n=36 Participants Total of all reporting groups
Age, Customized Age · age less than 18 years old	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Age · age between 18-70 years old	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Age, Customized Age · age less than 70 years old	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Apnea-Hypopnea Index >= 5/hr	23.6 events/hour STANDARD_DEVIATION 15.317 • n=5 Participants	28.8 events/hour STANDARD_DEVIATION 19.571 • n=7 Participants	26.1 events/hour STANDARD_DEVIATION 17.403 • n=5 Participants
BMI<= 35 kg/m^2	30.91 kg/m^2 STANDARD_DEVIATION 2.961 • n=5 Participants	29.89 kg/m^2 STANDARD_DEVIATION 3.543 • n=7 Participants	30.43 kg/m^2 STANDARD_DEVIATION 3.242 • n=5 Participants

PRIMARY outcome

Timeframe: per hour

Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.

The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. Difference of AHI values between patients who used the FRESCA treatment first versus the CPAP treatment.

Outcome measures

Outcome measures
Measure	FRESCA Mask First Night n=19 Participants First night using FRESCA nasal mask and second night using CPAP FRESCA Nasal Mask: FRESCA nasal mask	CPAP Mask First Night n=17 Participants One night using CPAP nasal mask and then second night using FRESCA nasal mask CPAP Nasal Mask: CPAP nasal pillow and nasal mask
Apnea Hypopnea Index (AHI) First Night	1.96 events per hour Standard Deviation 3.414	3.73 events per hour Standard Deviation 8.565
Apnea Hypopnea Index (AHI) Second Night	1.23 events per hour Standard Deviation 1.526	4.12 events per hour Standard Deviation 5.857
Apnea Hypopnea Index (AHI) Overall	2.98 events per hour Standard Deviation 4.783	2.41 events per hour Standard Deviation 6.028

PRIMARY outcome

Timeframe: per hour

Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.

The Oxygen Desaturation Index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline. The ODI is typically measured as part of standard sleep studies, such as a diagnostic polysomnogram, home sleep apnea testing, or with overnight oximetry.Difference of ODI values between patients who used the FRESCA treatment first versus the CPAP treatment.

Outcome measures

Outcome measures
Measure	FRESCA Mask First Night n=19 Participants First night using FRESCA nasal mask and second night using CPAP FRESCA Nasal Mask: FRESCA nasal mask	CPAP Mask First Night n=17 Participants One night using CPAP nasal mask and then second night using FRESCA nasal mask CPAP Nasal Mask: CPAP nasal pillow and nasal mask
Oxygen Desaturation Index (ODI) First Night	1.11 events per hour Standard Deviation 1.730	1.2 events per hour Standard Deviation 2.530
Oxygen Desaturation Index (ODI) Second Night	1.05 events per hour Standard Deviation 1.569	1.7 events per hour Standard Deviation 2.364
Oxygen Desaturation Index (ODI) Overall	1.39 events per hour Standard Deviation 2.046	1.12 events per hour Standard Deviation 2.049

SECONDARY outcome

Timeframe: per hour

Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.

The number of arousals per hour; arousals are defined as a change in EEG for at least 3 seconds.

Outcome measures

Outcome measures
Measure	FRESCA Mask First Night n=19 Participants First night using FRESCA nasal mask and second night using CPAP FRESCA Nasal Mask: FRESCA nasal mask	CPAP Mask First Night n=17 Participants One night using CPAP nasal mask and then second night using FRESCA nasal mask CPAP Nasal Mask: CPAP nasal pillow and nasal mask
Arousal Index (AI) First Night	21.95 events per hour Standard Deviation 15.572	20.94 events per hour Standard Deviation 8.728
Arousal Index (AI) Second Night	17.32 events per hour Standard Deviation 8.083	24.00 events per hour Standard Deviation 8.895
Arousal Index (AI) Overall	22.92 events per hour Standard Deviation 12.727	19.03 events per hour Standard Deviation 8.473

SECONDARY outcome

Timeframe: per night

Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.

Sleep Efficiency (%) \[100 x Total sleep time/ total recording time\] reported per treatment

Outcome measures

Outcome measures
Measure	FRESCA Mask First Night n=19 Participants First night using FRESCA nasal mask and second night using CPAP FRESCA Nasal Mask: FRESCA nasal mask	CPAP Mask First Night n=17 Participants One night using CPAP nasal mask and then second night using FRESCA nasal mask CPAP Nasal Mask: CPAP nasal pillow and nasal mask
Sleep Efficiency (SE%) First Night	80.63 percentage of sleep efficiency Standard Deviation 7.697	84.47 percentage of sleep efficiency Standard Deviation 11.549
Sleep Efficiency (SE%) Second Night	86.68 percentage of sleep efficiency Standard Deviation 7.212	78 percentage of sleep efficiency Standard Deviation 9.192
Sleep Efficiency (SE%) Overall	79.39 percentage of sleep efficiency Standard Deviation 8.419	85.64 percentage of sleep efficiency Standard Deviation 9.433

SECONDARY outcome

Timeframe: per night

The minimum O2 level percentage during treatment reported per treatment

Outcome measures

Outcome measures
Measure	FRESCA Mask First Night n=19 Participants First night using FRESCA nasal mask and second night using CPAP FRESCA Nasal Mask: FRESCA nasal mask	CPAP Mask First Night n=17 Participants One night using CPAP nasal mask and then second night using FRESCA nasal mask CPAP Nasal Mask: CPAP nasal pillow and nasal mask
Minimum Sleep SpO2 (%) First Night	89.16 percentage of O2 Saturation Standard Deviation 3.775	91.41 percentage of O2 Saturation Standard Deviation 3.858
Minimum Sleep SpO2 (%) Second Night	91.95 percentage of O2 Saturation Standard Deviation 2.321	89.06 percentage of O2 Saturation Standard Deviation 5.517
Minimum Sleep SpO2 (%) Overall	89.11 percentage of O2 Saturation Standard Deviation 4.609	91.69 percentage of O2 Saturation Standard Deviation 3.106

SECONDARY outcome

Timeframe: per night

Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.

Mean Sleep SpO2 - blood oxygenation level (%) mean value reported per treatment

Outcome measures

Outcome measures
Measure	FRESCA Mask First Night n=19 Participants First night using FRESCA nasal mask and second night using CPAP FRESCA Nasal Mask: FRESCA nasal mask	CPAP Mask First Night n=17 Participants One night using CPAP nasal mask and then second night using FRESCA nasal mask CPAP Nasal Mask: CPAP nasal pillow and nasal mask
Mean Sleep SpO2 -(%) First Night	94.89 percentage of O2 Saturation Standard Deviation 1.41	95.35 percentage of O2 Saturation Standard Deviation 1.498
Mean Sleep SpO2 -(%) Second Night	95 percentage of O2 Saturation Standard Deviation 1.414	95.41 percentage of O2 Saturation Standard Deviation 1.326
Mean Sleep SpO2 -(%) Overall	95.14 percentage of O2 Saturation Standard Deviation 1.376	95.17 percentage of O2 Saturation Standard Deviation 1.444

SECONDARY outcome

Timeframe: per night

Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.

Measure of time not sleeping (minutes)

Outcome measures

Outcome measures
Measure	FRESCA Mask First Night n=19 Participants First night using FRESCA nasal mask and second night using CPAP FRESCA Nasal Mask: FRESCA nasal mask	CPAP Mask First Night n=17 Participants One night using CPAP nasal mask and then second night using FRESCA nasal mask CPAP Nasal Mask: CPAP nasal pillow and nasal mask
Wakefulness (Min) First Night	78.95 minutes Standard Deviation 35.68	61.06 minutes Standard Deviation 58.463
Wakefulness (Min) Second Night	51.79 minutes Standard Deviation 32.898	90.88 minutes Standard Deviation 44.933
Wakefulness (Min) Overall	84.58 minutes Standard Deviation 40.177	56.17 minutes Standard Deviation 45.272

SECONDARY outcome

Timeframe: per night

Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.

Stage N1 sleep is an estimate of the degree of sleep fragmentation.

Outcome measures

Outcome measures
Measure	FRESCA Mask First Night n=19 Participants First night using FRESCA nasal mask and second night using CPAP FRESCA Nasal Mask: FRESCA nasal mask	CPAP Mask First Night n=17 Participants One night using CPAP nasal mask and then second night using FRESCA nasal mask CPAP Nasal Mask: CPAP nasal pillow and nasal mask
Stage N1 (Min) First Night	43.53 minutes Standard Deviation 20.614	49.88 minutes Standard Deviation 19.906
Stage N1 (Min) Second Night	40.26 minutes Standard Deviation 18.363	53.47 minutes Standard Deviation 25.873

SECONDARY outcome

Timeframe: per night

Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.

Stage N2 sleep predominates the sleep stages with 50% of the total sleep time. It follows the Stage N1 sleep and continues to recur throughout the night.

Outcome measures

Outcome measures
Measure	FRESCA Mask First Night n=19 Participants First night using FRESCA nasal mask and second night using CPAP FRESCA Nasal Mask: FRESCA nasal mask	CPAP Mask First Night n=17 Participants One night using CPAP nasal mask and then second night using FRESCA nasal mask CPAP Nasal Mask: CPAP nasal pillow and nasal mask
Stage N2 (Min) First Night	193.42 minutes Standard Deviation 55.529	198.41 minutes Standard Deviation 43.364
Stage N2 (Min) Second Night	214.89 minutes Standard Deviation 56.916	188.88 minutes Standard Deviation 45.862

SECONDARY outcome

Timeframe: per night

Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.

Stage N3 is considered as 'deep sleep'. It is sometimes referred as slow wave sleep.

Outcome measures

Outcome measures
Measure	FRESCA Mask First Night n=19 Participants First night using FRESCA nasal mask and second night using CPAP FRESCA Nasal Mask: FRESCA nasal mask	CPAP Mask First Night n=17 Participants One night using CPAP nasal mask and then second night using FRESCA nasal mask CPAP Nasal Mask: CPAP nasal pillow and nasal mask
Stage N3 (Min) First Night	59.21 minutes Standard Deviation 44.065	60.35 minutes Standard Deviation 50.447
Stage N3 (Min) Second Night	56.21 minutes Standard Deviation 48.433	42.94 minutes Standard Deviation 39.366

SECONDARY outcome

Timeframe: per night

Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.

The exact function of the REM is uncertain. However, it occupies approximately 25% of the total sleep time. REM sleep cycles occur every 90 to 120 min throughout the night with progressively increasing periods of time. REM sleep is associated with more frequent and longer duration apneas, hypopneas, and severe hypoxemia

Outcome measures

Outcome measures
Measure	FRESCA Mask First Night n=19 Participants First night using FRESCA nasal mask and second night using CPAP FRESCA Nasal Mask: FRESCA nasal mask	CPAP Mask First Night n=17 Participants One night using CPAP nasal mask and then second night using FRESCA nasal mask CPAP Nasal Mask: CPAP nasal pillow and nasal mask
REM (Min) First Night	60.63 minutes Standard Deviation 23.150	72.29 minutes Standard Deviation 26.343
REM (Min) Second Night	93.79 minutes Standard Deviation 31.101	58.82 minutes Standard Deviation 25.914

Adverse Events

FRESCA Mask

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

CPAP Mask

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	FRESCA Mask n=47 participants at risk Each patient used both devices, the analysis of the Adverse Events is recorded for both technology. This arm is associated with the FRESCA Mask.	CPAP Mask n=47 participants at risk Each patient used both devices, the analysis of the Adverse Events is recorded for both technology. This arm is associated with the CPAP Mask.
Respiratory, thoracic and mediastinal disorders Difficulty breathing through study device	8.5% 4/47 • Number of events 4 • All adverse events were record from the time they occurred. The 47 participants at risk include the 36 who completed the two sleep nights and the 11 who withdrew early.	0.00% 0/47 • All adverse events were record from the time they occurred. The 47 participants at risk include the 36 who completed the two sleep nights and the 11 who withdrew early.

Additional Information

Robert Lahaderne

FRESCA Medical

Phone: 949-542-3535

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place