AutoSet for Her Clinical Trial Protocol

Obstructive Sleep Apnea Clinical Trial

Official title:

AutoSet for Her Clinical Trial Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826513
• Other study ID #: MA13245678
• Status: Completed
• Phase: N/A
• First received: April 1, 2013
• Last updated: August 3, 2015
• Start date: May 2013
• Est. completion date: June 2013

Study information

• Verified date: November 2012
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Aging, Therapeutic Goods Association
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and user preference of the Newport AutoSet for Her in female obstructive sleep apnea (OSA) patients.

Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm.

User preference will be evaluated by subjective feedback relating to comfort, ease of falling asleep, sleep disturbance and feeling of being refreshed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pre-menopausal females aged = 18 years

• Current positive airway pressure (PAP)(CPAP or APAP) therapy user with 'current' defined as on PAP therapy for at least 1 month prior to study entry

• Diagnostic PSG available

• Diagnosis of mild-moderate OSA (AHI = 30)

• Participants willing and able to give written informed consent

Exclusion Criteria:

• Participants currently using Bi-level PAP

• Participants currently using supplemental oxygen

• Participants who are pregnant

• Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)

• Participants who the researcher believes are unsuitable for inclusion because either:

• they do not comprehend English

• they are unable to provide written informed consent

• they are physically unable to comply with the protocol

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• Modified AutoSet algorithm
An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.

Locations

Country	Name	City	State
Australia	West Australian Sleep Disorders Research Institute	Nedlands	Western Australia

Sponsors (2)

Lead Sponsor	Collaborator
ResMed	The University of Western Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnoea hypopnoea index (AHI)	Number of apnoeas and hypopnoeas per hour of sleep	2 days	No
Primary	Oxygen desaturation index (ODI)	Number of oxygen desaturations per hour of sleep	2 days	No
Secondary	Sleep efficacy	Sleep time in minutes divided by total time available for sleep	2 days	No
Secondary	Wake after sleep onset time	Time awake in minutes after initial sleep onset	2 days	No
Secondary	Time taken to fall asleep	Time in minutes taken to fall alseep	2 days	No
Secondary	Number of spontaneous arousals	Number of spontaneous arousals occurring over the entire total sleep time	2 days	No
Secondary	Number of hypopnoeas	Total number of hypopnoeas occurring in the total sleep time	2 days	No
Secondary	Number of obstructive apnoeas	Total number of obstructive apnoeas occurring in the total sleep time	2 days	No
Secondary	Number of central apnoeas	Total number of central apnoeas occurring in the total sleep time	2 days	No
Secondary	Oxygen saturation	Lowest oxygen saturation recorded in the total sleep time	2 days	No
Secondary	Time in sleep stages	Time in minutes spent in each sleep stage	2 days	No
Secondary	Number of respiratory event related arousals	Total number of respiratory event related arousals over the entire sleep period	2 days	No