AutoSet for Her Clinical Trial Protocol

NCT01826513 | Completed Results

• 1 other identifier: MA13245678
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea; Efficacy; Subjective feedback; Preference

Outcome Measures

Primary Outcomes (2)

• Apnoea Hypopnoea Index (AHI)

  Number of apnoeas and hypopnoeas per hour of sleep

  1 day

• Oxygen Desaturation Index (ODI)

  Number of oxygen desaturations per hour of sleep

  1 day

Secondary Outcomes (10)

• Sleep Efficacy

  1 day

• Wake After Sleep Onset Time

  1 day

• Time Taken to Fall Asleep

  1 day

• Number of Spontaneous Arousals

  1 day

• Number of Hypopnoeas

  1 day

Study Arms (3)

Unblinded Investigational Arm

EXPERIMENTAL

Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).

Device: Modified AutoSet algorithm

Standard AutoSet algorithm

ACTIVE COMPARATOR

Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.

Device: Standard AutoSet algorithm; Device: Modified AutoSet algorithm

Modified AutoSet algorithm

EXPERIMENTAL

Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night.

Device: Standard AutoSet algorithm; Device: Modified AutoSet algorithm

Interventions

Standard AutoSet algorithm DEVICE

An AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender.

Modified AutoSet algorithm; Standard AutoSet algorithm

Modified AutoSet algorithm DEVICE

An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.

Also known as: AutoSet for Her

Modified AutoSet algorithm; Standard AutoSet algorithm; Unblinded Investigational Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• they do not comprehend English
• they are unable to provide written informed consent
• they are physically unable to comply with the protocol

Sponsors & Collaborators

• ResMed: lead
• The University of Western Australia: collaborator

Study Sites (1)

West Australian Sleep Disorders Research Institute

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Prof. David Hillman & Prof. Peter Eastwood
• Organization: University of Western Australia

peter.eastwood@health.wa.gov.au

+61 8 9346 1706

Study Officials

• Peter Eastwood, MBBS FRACP

  Centre for Sleep Science, University of Western Australia

  PRINCIPAL INVESTIGATOR

• David Hillman, MBBS FRACP

  West Australian Sleep Disorders Reserach Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 8, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 27, 2017
• Results First Posted: March 27, 2017

Record last verified: 2017-02

Locations

AU (1)