## Protocol Section
### Identification Module
**NCT ID:** NCT01824979

**Brief Title:** Pilairo Lab Market Research

**Official Title:** Pilairo Lab Market Research

#### Organization Study ID Info
**ID:** CIA76
#### Organization
**Class:** INDUSTRY
**Full Name:** Fisher and Paykel Healthcare
### Status Module
#### Completion Date
**Date:** 2013-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-03-09

**Type:** ACTUAL

**Last Update Submit Date:** 2018-02-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-05

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2018-03-09

**Type:** ACTUAL

**Results First Submit Date:** 2017-08-02

**Results First Submit QC Date:** 2018-02-08

#### Start Date
**Date:** 2012-12

**Status Verified Date:** 2018-02

#### Study First Post Date
**Date:** 2013-04-05
**Type:** ESTIMATED
**Study First Submit Date:** 2013-04-02
**Study First Submit QC Date:** 2013-04-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Fisher and Paykel Healthcare

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of the study is to observe the Pilairo mask in a lab setting.

**Detailed Description:** The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other commercially available masks for continuous positive airwary pressure (CPAP) therapy.

### Conditions Module

**Conditions:**

- Obstructive Sleep Apnea

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Pilairo nasal pillows mask during CPAP titration

**Intervention Names:**

- Device: CPAP mask ( Pilairo)

**Label:** Pilairo mask

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Other CPAP mask during CPAP titration

**Intervention Names:**

- Procedure: Other CPAP mask

**Label:** Other CPAP mask

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pilairo mask

**Name:** CPAP mask ( Pilairo)

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Other CPAP mask

**Name:** Other CPAP mask

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience.

**Measure:** Technician Experience With Mask

**Time Frame:** One night

#### Secondary Outcomes

**Description:** Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort.

**Measure:** Number of Mask Interventions During the Night

**Time Frame:** One night

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Apnea Hypopnea Indea \>15 from diagnostic study
* Minimum 18 years of age

Exclusion Criteria:

* Inability ot give informed consent
* History of intolerance to CPAP
* Anatomical or physiological conditions making CPAP therapy inappropriate

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Burlingame

**Country:** United States

**Facility:** Peninsula Sleep Center Inc

**State:** California

**Zip:** 94010

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012891

- Term: Sleep Apnea Syndromes

- ID: D000001049

- Term: Apnea

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000020919

- Term: Sleep Disorders, Intrinsic

- ID: D000020920

- Term: Dyssomnias

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M4361

- Name: Apnea

- Relevance: LOW

- As Found: Unknown

- ID: M15694

- Name: Sleep Apnea Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M22010

- Name: Sleep Apnea, Obstructive

- Relevance: HIGH

- As Found: Obstructive Sleep Apnea

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22242

- Name: Parasomnias

- Relevance: LOW

- As Found: Unknown

- ID: M22654

- Name: Sleep Disorders, Intrinsic

- Relevance: LOW

- As Found: Unknown

- ID: M22655

- Name: Dyssomnias

- Relevance: LOW

- As Found: Unknown

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020181

- Term: Sleep Apnea, Obstructive

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Pilairo

**Deaths Num At Risk:** 50

**Description:** Pilairo nasal pillows mask during CPAP titration

CPAP mask ( Pilairo)

**ID:** EG000

**Other Num at Risk:** 50

**Serious Number At Risk:** 50

**Title:** Pilairo

**Group ID:** EG001

**Title:** Other CPAP Mask

**Deaths Num At Risk:** 50

**Description:** Other CPAP mask during CPAP titration

Other CPAP mask

**ID:** EG001

**Other Num at Risk:** 50

**Serious Number At Risk:** 50

**Title:** Other CPAP Mask

**Frequency Threshold:** 0

**Time Frame:** 1 night in lab

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 50

**Group ID:** BG001

**Value:** 50

**Group ID:** BG002

**Value:** 100

**Units:** Participants

### Group

**ID:** BG000

**Title:** Pilairo

**Description:** Pilairo nasal pillows mask during CPAP titration

CPAP mask ( Pilairo)

### Group

**ID:** BG001

**Title:** Other CPAP Mask

**Description:** Other CPAP mask during CPAP titration

Other CPAP mask

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 50

#### Measurement

**Group ID:** BG001

**Value:** 50

#### Measurement

**Group ID:** BG002

**Value:** 100

**Class Title:** ≥ 18 years

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 19

#### Measurement

**Group ID:** BG002

**Value:** 29

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 40

#### Measurement

**Group ID:** BG001

**Value:** 31

#### Measurement

**Group ID:** BG002

**Value:** 71

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 50

#### Measurement

**Group ID:** BG001

**Value:** 50

#### Measurement

**Group ID:** BG002

**Value:** 100

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Description:** Inclusion criteria only confirmed participants were over the age of 18. Full date of birth was not recorded on the case report form. Therefore, the exact breakdown of participants in each age bracket is unable to be provided as is required in the non-customized Baseline measure.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** CPAPtrial@fphcare.co.nz
**Organization:** Fisher and Paykel Healthcare
**Phone:** + 64 09 574 0100
**Title:** Clinical Research Scientist
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 10
- **Value:** 8.46
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 10
- **Value:** 8.24
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 1.29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 2.20
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience.
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Population Description:** While not all participants completed the full study, a number of participants had completed enough of the study to provide data to analyze. For this outcome measure, 48 participants in the Pilairo Group had usable data for analysis while 42 participants in the Other CPAP mask group had usable data for analysis for this measure.
**Reporting Status:** POSTED
**Time Frame:** One night
**Title:** Technician Experience With Mask
**Type:** PRIMARY
**Unit of Measure:** Units on a Scale
##### Group
**Description:** Pilairo nasal pillows mask during CPAP titration

CPAP mask ( Pilairo)
**ID:** OG000
**Title:** Pilairo
##### Group
**Description:** Other CPAP mask during CPAP titration

Other CPAP mask
**ID:** OG001
**Title:** Other CPAP Mask
#### Outcome Measure 2
**Description:** Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort.
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Population Description:** While not all participants completed the full study, a number of participants had completed enough of the study to provide data to analyze. For this outcome measure, 48 participants in the Pilairo Group had usable data for analysis while 42 participants in the Other CPAP mask group had usable data for analysis for this measure.
**Reporting Status:** POSTED
**Time Frame:** One night
**Title:** Number of Mask Interventions During the Night
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Pilairo nasal pillows mask during CPAP titration

CPAP mask ( Pilairo)
**ID:** OG000
**Title:** Pilairo
##### Group
**Description:** Other CPAP mask during CPAP titration

Other CPAP mask
**ID:** OG001
**Title:** Other CPAP Mask
### Participant Flow Module
#### Group
**Description:** Pilairo nasal pillows mask during CPAP titration

CPAP mask ( Pilairo)
**ID:** FG000
**Title:** Pilairo
#### Group
**Description:** Other CPAP mask during CPAP titration

Other CPAP mask
**ID:** FG001
**Title:** Other CPAP Mask
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 6
###### Reason
**Group ID:** FG001
**Number of Subjects:** 13
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 50
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 50
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 37
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 37
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 13
**Has Results:** True