Trial Outcomes & Findings for Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA) (NCT NCT04029311)

NCT ID: NCT04029311

Last Updated: 2021-04-02

Results Overview

Episodes per hour that the patient experiences apneas and/or hypopneas

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: 2 months
• Results posted on: 2021-04-02

Participant Flow

Participant milestones

Measure	Combination Therapy With Preferred Mask Preferred Mask refers to a type of existing medical mask used for Positive Airway Pressure (PAP) therapy. Nuance Pro: Study compares Nuance Pro plus Automatic Positive Airway (autoPAP ) vs TAP PAP plus autoPAP autoPAP: autoPAP	Combination Therapy With Custom Mask Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. autoPAP: autoPAP TAP PAP: TAP PAP
Overall Study STARTED	15	13
Overall Study COMPLETED	12	13
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Combination Therapy With Preferred Mask n=15 Participants Preferred Mask refers to a type of existing medical mask used for PAP therapy. Nuance Pro: Study compares Nuance Pro plus autoPAP vs TAP PAP plus autoPAP autoPAP: autoPAP	Combination Therapy With Custom Mask n=13 Participants Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. autoPAP: autoPAP TAP PAP: TAP PAP	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=15 Participants	0 Participants n=13 Participants	0 Participants n=28 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=15 Participants	11 Participants n=13 Participants	20 Participants n=28 Participants
Age, Categorical >=65 years	6 Participants n=15 Participants	2 Participants n=13 Participants	8 Participants n=28 Participants
Age, Continuous	57.9 years STANDARD_DEVIATION 12.7 • n=15 Participants	54.5 years STANDARD_DEVIATION 8.6 • n=13 Participants	56.3 years STANDARD_DEVIATION 10.9 • n=28 Participants
Sex: Female, Male Female	9 Participants n=15 Participants	6 Participants n=13 Participants	15 Participants n=28 Participants
Sex: Female, Male Male	6 Participants n=15 Participants	7 Participants n=13 Participants	13 Participants n=28 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	15 participants n=15 Participants	13 participants n=13 Participants	28 participants n=28 Participants
BMI	34.4 kg/m^2 STANDARD_DEVIATION 8.4 • n=15 Participants	32.9 kg/m^2 STANDARD_DEVIATION 7.5 • n=13 Participants	33.8 kg/m^2 STANDARD_DEVIATION 7.9 • n=28 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Missing data from 1 participant in Combination Therapy with Preferred Mask group

Episodes per hour that the patient experiences apneas and/or hypopneas

Outcome measures

Measure	Combination Therapy With Preferred Mask n=11 Participants Preferred Mask refers to a type of existing medical mask used for PAP therapy. Nuance Pro: Study compares Nuance Pro plus autoPAP vs TAP PAP plus autoPAP autoPAP: autoPAP	Combination Therapy With Custom Mask n=13 Participants Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. autoPAP: autoPAP TAP PAP: TAP PAP
Apnea-Hypopnea Index	4.1 episodes/hour Standard Deviation 3.6	3.6 episodes/hour Standard Deviation 2.7

PRIMARY outcome

Timeframe: 2 months

Population: Missing data from 1 participant in Combination Therapy with Preferred Mask group.

The pressure required to treat the patient successfully

Outcome measures

Measure	Combination Therapy With Preferred Mask n=11 Participants Preferred Mask refers to a type of existing medical mask used for PAP therapy. Nuance Pro: Study compares Nuance Pro plus autoPAP vs TAP PAP plus autoPAP autoPAP: autoPAP	Combination Therapy With Custom Mask n=13 Participants Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. autoPAP: autoPAP TAP PAP: TAP PAP
PAP Pressure	9.6 cmH2O Standard Deviation 1.8	8.6 cmH2O Standard Deviation 1.9

PRIMARY outcome

Timeframe: 2 months

Population: Missing data from 1 participant in Combination Therapy with Preferred Mask group.

The Liters/Minute of leaking of the PAP machine

Outcome measures

Measure	Combination Therapy With Preferred Mask n=11 Participants Preferred Mask refers to a type of existing medical mask used for PAP therapy. Nuance Pro: Study compares Nuance Pro plus autoPAP vs TAP PAP plus autoPAP autoPAP: autoPAP	Combination Therapy With Custom Mask n=13 Participants Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. autoPAP: autoPAP TAP PAP: TAP PAP
Leaks	15.1 L/min Standard Deviation 8.0	16.7 L/min Standard Deviation 14.1

PRIMARY outcome

Timeframe: 2 months

Population: Missing data from 1 participant in Combination Therapy with Preferred Mask group.

The average hours of use per night of each of the combination therapies

Outcome measures

Measure	Combination Therapy With Preferred Mask n=11 Participants Preferred Mask refers to a type of existing medical mask used for PAP therapy. Nuance Pro: Study compares Nuance Pro plus autoPAP vs TAP PAP plus autoPAP autoPAP: autoPAP	Combination Therapy With Custom Mask n=13 Participants Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. autoPAP: autoPAP TAP PAP: TAP PAP
Hours of Use	6.0 hours per night Standard Deviation 1.9	5.9 hours per night Standard Deviation 2.4

PRIMARY outcome

Timeframe: 2 months

Population: Missing data from 1 participant in Combination Therapy with Preferred Mask group.

The ESS is a self-administered questionnaire with 8 questions. The score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life.

Outcome measures

Measure	Combination Therapy With Preferred Mask n=11 Participants Preferred Mask refers to a type of existing medical mask used for PAP therapy. Nuance Pro: Study compares Nuance Pro plus autoPAP vs TAP PAP plus autoPAP autoPAP: autoPAP	Combination Therapy With Custom Mask n=13 Participants Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. autoPAP: autoPAP TAP PAP: TAP PAP
Epworth Sleepiness Scale (ESS)	5.5 score on a scale Standard Deviation 4.0	5.8 score on a scale Standard Deviation 2.7

PRIMARY outcome

Timeframe: 2 months

Population: Missing data from 1 participant in Combination Therapy with Preferred Mask group.

FOSQ is a disease specific quality of life questionnaire to determine how sleepiness interferes one's quality of life. The total score range from 5 to 20 (10 questions, 1-4 points per each). The lower values represent a worse quality of life.

Outcome measures

Measure	Combination Therapy With Preferred Mask n=11 Participants Preferred Mask refers to a type of existing medical mask used for PAP therapy. Nuance Pro: Study compares Nuance Pro plus autoPAP vs TAP PAP plus autoPAP autoPAP: autoPAP	Combination Therapy With Custom Mask n=13 Participants Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. autoPAP: autoPAP TAP PAP: TAP PAP
Functional Outcomes Sleep Questionnaire (FOSQ)	36.3 score on a scale Standard Deviation 3.8	36.2 score on a scale Standard Deviation 2.8

PRIMARY outcome

Timeframe: 2 months

This questionnaire consists of 4 questions to determine the frequency of 4 typical side-effects from positive airway pressure therapy. The score ranges from 0 to 16 (4 questions, 0-4 points per each). The higher value represent worse side effects.

Outcome measures

Measure	Combination Therapy With Preferred Mask n=11 Participants Preferred Mask refers to a type of existing medical mask used for PAP therapy. Nuance Pro: Study compares Nuance Pro plus autoPAP vs TAP PAP plus autoPAP autoPAP: autoPAP	Combination Therapy With Custom Mask n=13 Participants Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. autoPAP: autoPAP TAP PAP: TAP PAP
Intolerance Questionnaire	2.7 score on a scale Standard Deviation 2.4	3.4 score on a scale Standard Deviation 2.7

Adverse Events

Combination Therapy With Preferred Mask

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combination Therapy With Custom 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

Adverse event data not reported

Additional Information

Dr. Yasue Tanaka

Tohoku University

Phone: +81227178396

Email: yasue.tanaka.b3@tohoku.ac.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place