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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12625001128482
Ethics application status
Approved
Date submitted
26/08/2025
Date registered
15/10/2025
Date last updated
15/10/2025
Date data sharing statement initially provided
15/10/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Neuromodulation therapy to treat obstructive sleep apnea
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Scientific title
An Early Feasibility Study of Neuromodulation Therapy for Obstructive Sleep Apnea
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Secondary ID [1]
315090
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea
338488
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Condition category
Condition code
Respiratory
334793
334793
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0
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Sleep apnoea
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The Restora Clinical System (RCS) consists of implantable pulse generator (IPG) and its accessories, 2 lead wires implanted on the two targeted nerves, and an adapter connecting lead wires and IPG. The RCS system will be implanted during surgery by a head and neck surgeon. RCS is intended to unilaterally stimulate the hypoglossal nerve which innervates the muscles in the tongue and the ansa cervicalis nerve which innervates the infrahyoid muscles. The device is intended to be used by the participant every night during sleep period.
After device implantation (approximately 60 minutes), participants will need to complete the following study procedures:
- Follow-up visits at the study clinic to complete quality of life questionnaires (approximately 30 minutes) at 1, 3, 6, 9, 12, 18 and 24 months post-device implantation
- Overnight polysomnography visits (minimum 8 hours) at the study sleep clinic at 1, 2, 3, 6, 12 and 24 months post-device implantation (to be completed after quality of life questionnaires, as applicable to the visit)
- Home sleep apnea tests (minimum 8 hours for 3 nights) at the participant’s home at 1, 2, 3, and 6 months post-device implantation (to be completed after overnight polysomnography)
The study period is 2 years, participants are allowed to continue to use RCS in accordance with standard of care. Participants will be closely monitored by study team using aforementioned study procedures.
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Intervention code [1]
331706
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Treatment: Devices
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Comparator / control treatment
None
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Device and procedure related serious adverse events, such as life-threatening illness, prolonged hospitalization, or death
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Assessment method [1]
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Adverse event will be closely monitored and collected through clinical assessment and reviewing medical records by qualified study team
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Timepoint [1]
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Clinical assessed at hospital discharge, 1 week, 1 month, 2 month, 3 month, 6 month (primary timepoint), 9 month, 12 month, 18 month, 24 month post-device implantation
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Primary outcome [2]
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Apnea hypopnea index (AHI) changes
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Assessment method [2]
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Assessed by polysomnography (PSG)
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Timepoint [2]
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Baseline, 1 month, 2 month, 3 month, 6 month (primary timepoint), 12 month, and 24 month post-device implantation
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Primary outcome [3]
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Oxygen desaturation index (ODI) changes
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Assessment method [3]
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Assessed by polysomnography (PSG)
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Timepoint [3]
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Baseline, 1 month, 2 month, 3 month, 6 month (primary timepoint), 12 month, and 24 month post-device implantation
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Secondary outcome [1]
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Responder rate based on AHI
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Assessment method [1]
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Assessed by polysomnography (PSG)
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Timepoint [1]
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Baseline, 1 month, 2 month, 3 month, 6 month (secondary timepoint), 12 month, and 24 month post-device implantation
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Secondary outcome [2]
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Responder rate based on ODI
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Assessment method [2]
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Assessed by polysomnography (PSG)
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Timepoint [2]
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Baseline, 1 month, 2 month, 3 month, 6 month (secondary timepoint), 12 month, and 24 month post-device implantation
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Secondary outcome [3]
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Percentage of time spent in SaO2 <90% changes
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Assessment method [3]
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Assessed by polysomnography (PSG)
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Timepoint [3]
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Baseline, 1 month, 2 month, 3 month, 6 month (secondary timepoint), 12 month, and 24 month post-device implantation
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Secondary outcome [4]
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Sleepiness
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Assessment method [4]
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Assessed by Epworth Sleepiness Scale
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Timepoint [4]
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Baseline, 1 month, 3 month, 6 month (secondary timepoint), 9 month, 12 month, 18 month, 24 month post-device implantation
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Secondary outcome [5]
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Quality of life
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Assessment method [5]
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Assessed by Functional Outcome of Sleep Short Form
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Timepoint [5]
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Baseline, 1 month, 3 month, 6 month (secondary timepoint), 9 month, 12 month, 18 month, 24 month post-device implantation
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Secondary outcome [6]
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Fatigue
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Assessment method [6]
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Assessed by PROMIS Fatigue Form
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Timepoint [6]
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Baseline, 1 month, 3 month, 6 month (secondary timepoint), 9 month, 12 month, 18 month, 24 month post-device implantation
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Secondary outcome [7]
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Sleep Disturbance
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Assessment method [7]
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Assessed by PROMIS Sleep Disturbance Short Form
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Timepoint [7]
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Baseline, 1 month, 3 month, 6 month (secondary timepoint), 9 month, 12 month, 18 month, 24 month post-device implantation
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Secondary outcome [8]
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Sleep Impairment
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Assessment method [8]
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Assessed by Sleep Impairment Short Form
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Timepoint [8]
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Baseline, 1 month, 3 month, 6 month (secondary timepoint), 9 month, 12 month, 18 month, 24 month post-device implantation
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Secondary outcome [9]
453239
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Snoring
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Assessment method [9]
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Assessed by Snoring Form
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Timepoint [9]
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Baseline, 1 month, 3 month, 6 month (secondary timepoint), 9 month, 12 month, 18 month, 24 month post-device implantation
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Eligibility
Key inclusion criteria
- AHI greater than or equal to 15 events per hour
-Body mass index (BMI) less than or equal too 35 kg/m2
-Participants followed standard of care in considering all other alternative/adjunct therapies and failed or not tolerated CPAP treatment
-Willing and capable to consent, of having stimulation hardware permanently implanted, and using the device, and of complying with protocol requirements
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Minimum age
22
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
-BMI < 20 kg/m2
-AHI > 65 events per hour
-Central or mix apnea and hypopnea > 25%
-In the opinion of the investigator, concomitant sleep disorders that are not adequately treated and could confound functional assessments of sleepiness, or taking medications that may alter consciousness, the pattern of respiration, or sleep architecture.
-Significantly enlarged goiter at intended implant side or planned thyroidectomy in the next 6 months
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
31/10/2025
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Actual
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Date of last participant enrolment
Anticipated
1/01/2026
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Actual
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Date of last data collection
Anticipated
1/01/2028
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment outside Australia
Country [1]
27279
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Singapore
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State/province [1]
27279
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Funding & Sponsors
Funding source category [1]
319662
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Commercial sector/Industry
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Name [1]
319662
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Restora Medical
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Address [1]
319662
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Country [1]
319662
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Restora Medical
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Address
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Country
United States of America
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Secondary sponsor category [1]
322209
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Commercial sector/Industry
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Name [1]
322209
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Restora Medical Australia Pty Ltd
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Address [1]
322209
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Country [1]
322209
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
318226
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Bellberry Human Research Ethics Committee A
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Ethics committee address [1]
318226
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https://bellberry.com.au/
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Ethics committee country [1]
318226
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Australia
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Date submitted for ethics approval [1]
318226
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18/06/2025
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Approval date [1]
318226
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09/09/2025
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Ethics approval number [1]
318226
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Summary
Brief summary
Hypoglossal nerve stimulation (HNS) has been shown to be a safe and effective treatment option for patients with moderate to severe obstructive sleep apnea (OSA). However, since the introduction of HNS in clinical practice, approximately one third of the implanted patients do not demonstrate clinically meaningful improvement. This study will evaluate whether chronic ansa cerivalis stimulation (ACS) in combination with HNS during natural sleep will yield a clinical meaningful improvement for OSA patients.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Zheng Lin
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Address
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Restora Medical, 2603 Main St. Suite 770, Irvine, CA 92614
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Country
143494
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United States of America
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Phone
143494
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+1 949 932 0243
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Fax
143494
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Email
143494
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[email protected]
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Contact person for public queries
Name
143495
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Zheng Lin
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Address
143495
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Restora Medical, 2603 Main St. Suite 770, Irvine, CA 92614
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Country
143495
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United States of America
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Phone
143495
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+1 949 932 0243
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
143496
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Zheng Lin
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Address
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Restora Medical, 2603 Main St. Suite 770, Irvine, CA 92614
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Country
143496
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United States of America
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Phone
143496
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+1 949 932 0243
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Fax
143496
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Email
143496
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF