Obstructive Sleep Apnea SyndromeAIRSTIMNCT03844295

Obstructive Sleep Apnea Therapy by Stimulation of the Hypoglossal Nerve

A study testing Activated Inspire® Upper Airway Stimulation System and Inactivated Inspire® Upper Airway Stimulation System in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Grenoble at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Obstructive Sleep Apnea Syndrome
What is being tested?: Activated Inspire® Upper Airway Stimulation System and Inactivated Inspire® Upper Airway Stimulation System
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 7 participants
Where: 1 siteFrance
Study dates: 21 Mar 2019to 10 Oct 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient aged 18 to 80 years old
Patient with moderate to severe OSA based on an established diagnosis of OSA (15≤AHI<65) by polysomnography or respiratory polygraphy not older thant three years.
Patient with moderate to severe OSA naïve of treatment or with difficulty accepting or adhering to CPAP treatment.
Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer to activate the stimulation
Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
Willing and capable of providing written informed consent.

Who cannot join

Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
Have any condition or procedure that has compromised neurological control of the upper airway
Unable to operate the patient programmer
Pregnant or plan to become pregnant, and breastfeeding women
Require magnetic resonance imaging (MRI)
Have an implantable device that may be susceptible to unintended interaction with the Inspire system.

Show all 32Show fewer

Additional exclusions for study purposes only
Body Mass Index (BMI) of >32
Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
Neuromuscular disease
Hypoglossal-nerve palsy
Severe restrictive or obstructive pulmonary disease
Moderate-to-severe pulmonary arterial hypertension
Severe valvular heart disease
New York Heart Association class III or IV heart failure
Recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months)
Persistent uncontrolled hypertension despite medication use
Coexisting nonrespiratory sleep disorders that would confound functional sleep assessment
Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
a terminal illness with life expectancy < 12 months
Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
Radiotherapy or ablation therapy of the head and/or neck
Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat(with exception of tonsillectomy and/or adenoidectomy)
Previous surgery within 3 months performed on the soft-palate tissue
Obvious fixed upper airway obstructions (tumors, polyps, unilateral nasal obstruction)
Need for chronic supplemental oxygen therapy for any other reason, pO2 (partial pressure of oxygen) < 55 mm Hg
Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months
Patients on medication that may alter consciousness, the pattern of respiration or sleep architecture (for example, benzodiazepiones, opiates, neuroleptics, prescription stimulants, phenothiazine, or any form of chemical substance abuse)
Patients taking blood thinning medications (for example warfarin, aspirin, plavix or other blood thinning agents which cannot be safety stopped or bridged temporarily to allow surgery to take place)
Any other reason for the investigator deems that the subject is unfit for participation in the study
Subject in exclusion period for another study
Subject under administrative or judicial control.

Trial locations and contacts

1 site in 1 country.

France1 site

UniversityHospitalGrenoble
Grenoble, 38043

Other trials in France

About this study

Official title: Upper AIRway Implanted Nerve STIMulation Therapy: A Breakthrough in Obstructive Sleep Apnea Therapy

Continuous positive airway pressure (CPAP) is the gold standard to normalize breathing during sleep in patients with obstructive sleep apnea syndrom (OSA). Many patients will not tolerate or will not accept CPAP. Implanted nerve stimulation is a novel therapy for OSA patients that restores the upper airway potency using unilateral XII nerve electric stimulation.

The principal objective of this study is short-term efficacy of a new treatment for OSA on blood pressure variability during sleep.

Read the detailed description

Obstructive sleep apnea (OSA) syndrome had become over the last decade a serious health concern due to its high prevalence which raise 10% of the general population.

It is characterized by recurrent episodes of airflow obstruction in the upper airway (UA) consequence of passive collapse of the UA, particularly at the tongue level. These collapses induce recurrent asphyxia that results in oxygen desaturations with persistant and crescendo respiratory efforts inducing arousals from sleep.

Indeed, despite its large efficacy some of the patients will never accept continuous positive airway pressure treatment or will not tolerate. To this extent, alternative treatement has been developed: implanted hypoglossal stimulation. This treatment has been developed by Inspire Medical Device. The Inspire® system is intended to prevent base-of-tongue obstruction as well as specific soft palate obstructions by stimulating the hypoglossal nerve synchronous with respiration.

A selection processus will be applied in order to identify the patients that will be good responders to the hypoglossal stimulation.

The main criterion of selection is based on Drug Induced Sleep Endoscopy(DISE) that will be performed by a trained endoscopist dedicated to this study.

This sleep endoscopy allows to visualize during induced sleep the shape of the UA and the type of collapsus. Indeed an antero-posterior collapsus is related to a good response to hypoglossal nerve stimulation while complete concentric obstruction at velopharyngeal is a predictor of poor response.

In this pilot study, the investigators evaluate as a primary outcome the delta range of blood pressure during sleep but also other cardiovascular indexes targeting blood pressure and heart rate variability as secondary outcomes.

Conditions: Obstructive Sleep Apnea Syndrome
Being tested: Activated Inspire® Upper Airway Stimulation System, Inactivated Inspire® Upper Airway Stimulation System
Keywords: stimulation, hypoglossal nerve, Upper-airway
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Activated Inspire® Upper Airway Stimulation SystemDevice
At first, INSPIRE® device will be active a month
Inactivated Inspire® Upper Airway Stimulation SystemDevice
After 15 days "wash-out" INSPIRE® device will be inactivated for a second period of one month.

Study groups in NCT03844295
Study group	Role	What they receive
Activated Inspire® Upper Airway Stimulation System	Experimental	INSPIRE® device will be active a month Receives: Device: Activated Inspire® Upper Airway Stimulation System
Inactivated Inspire® Upper Airway Stimulation System	Placebo comparator	After a period 15 days of "wash-out" the INSPIRE® device will be inactivated for a second period of one month. Receives: Device: Inactivated Inspire® Upper Airway Stimulation System

What is being measured

The primary outcome is the main question the study is designed to answer.

Short-term efficacy of a new treatment for OSA on systolic blood pressure variability during sleep
Change in the difference between delta nocturnal systolic blood pressure (difference between maximum and minimal nocturnal systolic blood pressure ; nocturnal period is defined from 10 pm to 7am).
Measured: one month treatment active versus non active treatment

Secondary outcomes (16)

Short-term efficacy of a new treatment for OSA on mean-24h, daytime and nighttime blood pressure
Ambulatory 24h arterial blood pressure
Measured: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on OSA by Epworth sleepiness scale score
It's a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person has daytime sleepiness.
Measured: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on Apnea-Hypopnea Index measured by polysomnography
Apnea-Hypopnea Index expressed in number per hour
Measured: one month treatment active versus non active treatment
Change in sympatho-vagal balance based on heart rate variability analysis
ECG polysomnography
Measured: one month treatment active versus non active treatment
Self-reported changes in sleep and quality of life by SF-36 score
The SF-36 is a 36-item scale constructed to survey health status and quality of life (Ware \& Sherbourne, 1992), assessing eight health concepts: limitations in Quality of life physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems); bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. The standard form of the instruments asks for participants to reply to questions according to how they have felt over the previous week. The items use Likert-type scales, some with 5 or 6 points and others with 2 or 3 points. The SF-36 has been widely used and has excellent psychometrics.
Measured: one month treatment active versus non active treatment
Sleep latency assessed during a Maintenance of Wakefulness Test
Mean sleep latency from the 4 sessions of the Maintenance of Wakefulness Test
Measured: one month treatment active versus non active treatment
Nocturnal pulse pressure assessed by Continuous Non-invasive Arterial Pressure monitoring
Pulse pressure variability indexe DeltaBP in mmHg.
Measured: one month treatment active versus non active treatment
Short-term efficacy of a new treatment for OSA on diastolic blood pressure variability during sleep
Change in the difference between delta nocturnal systolic blood pressure (difference between maximum and minimal nocturnal systolic blood pressure ; nocturnal period is defined from 10 pm to 7am).
Measured: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on OSA by Pichot weakness scale score
It's a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 5-point scale (0-4), their usual feeling of tiredness or weakness while engaged in eight different activities. The PWS score (the sum of 8 item scores, 0-4) can range from 0 to 32. The higher the PWS score, the higher that person has weakness.
Measured: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on nocturia
Assessment of nocturia number by nigt
Measured: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on morning asthenia
Patients are asked to assess, on a visual analogic scale morning asthenia. The items use a visual analogic scales from 0 to 10 points.
Measured: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on morning headache
Patients are asked to assess, on a visual analogic scale morning headache. The items use a visual analogic scales from 0 to 10 points.
Measured: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on snoring
Patients are asked to assess, on a visual analogic scale snoring. The items use a visual analogic scales from 0 to 10 points.
Measured: one month treatment active versus non active treatment
Self-reported changes in sleep and quality of life by FOSQ score
This is a disease specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. The 5 domains that the FOSQ measures are as follows: Activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, rate the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty).
Measured: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on oxygen desaturation index measured by polysomnography
Oxygen desaturation index expressed in number
Measured: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on sleep efficacy measured by polysomnography
Sleep efficacy expressed by ratio of total sleep time on total sleep period
Measured: one month treatment active versus non active treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 201910 Oct 2023

First posted18 Feb 2019
Study start21 Mar 2019
Primary completion22 Dec 2021
Study completion10 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Monocentric, prospective, controlled, patient single-blind study
Masking: Single blind
Who is masked: Participant
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03844295
Sponsor's protocol ID: 38RC18.030
Acronym: AIRSTIM
Status last verified: Jul 2024
First submitted: 18 Oct 2018
Last updated: 26 Jul 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
PubMed 8464434
Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.
PubMed 11991871
Mulgrew AT, Ryan CF, Fleetham JA, Cheema R, Fox N, Koehoorn M, Fitzgerald JM, Marra C, Ayas NT. The impact of obstructive sleep apnea and daytime sleepiness on work limitation. Sleep Med. 2007 Dec;9(1):42-53. doi: 10.1016/j.sleep.2007.01.009. Epub 2007 Sep 6.
PubMed 17825611
Lallukka T, Kaikkonen R, Harkanen T, Kronholm E, Partonen T, Rahkonen O, Koskinen S. Sleep and sickness absence: a nationally representative register-based follow-up study. Sleep. 2014 Sep 1;37(9):1413-25. doi: 10.5665/sleep.3986.
PubMed 25142569
Tamisier R, Pepin JL, Remy J, Baguet JP, Taylor JA, Weiss JW, Levy P. 14 nights of intermittent hypoxia elevate daytime blood pressure and sympathetic activity in healthy humans. Eur Respir J. 2011 Jan;37(1):119-28. doi: 10.1183/09031936.00204209. Epub 2010 Jun 4.
PubMed 20525723
Pepin JL, Tamisier R, Barone-Rochette G, Launois SH, Levy P, Baguet JP. Comparison of continuous positive airway pressure and valsartan in hypertensive patients with sleep apnea. Am J Respir Crit Care Med. 2010 Oct 1;182(7):954-60. doi: 10.1164/rccm.200912-1803OC. Epub 2010 Jun 3.
PubMed 20522795
Gagnadoux F, Fleury B, Vielle B, Petelle B, Meslier N, N'Guyen XL, Trzepizur W, Racineux JL. Titrated mandibular advancement versus positive airway pressure for sleep apnoea. Eur Respir J. 2009 Oct;34(4):914-20. doi: 10.1183/09031936.00148208. Epub 2009 Mar 26.
PubMed 19324954
Strollo PJ Jr, Soose RJ, Maurer JT, de Vries N, Cornelius J, Froymovich O, Hanson RD, Padhya TA, Steward DL, Gillespie MB, Woodson BT, Van de Heyning PH, Goetting MG, Vanderveken OM, Feldman N, Knaack L, Strohl KP; STAR Trial Group. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014 Jan 9;370(2):139-49. doi: 10.1056/NEJMoa1308659.
PubMed 24401051
Mayer P, Pepin JL, Bettega G, Veale D, Ferretti G, Deschaux C, Levy P. Relationship between body mass index, age and upper airway measurements in snorers and sleep apnoea patients. Eur Respir J. 1996 Sep;9(9):1801-9. doi: 10.1183/09031936.96.09091801.
PubMed 8880094
Eastwood PR, Barnes M, Walsh JH, Maddison KJ, Hee G, Schwartz AR, Smith PL, Malhotra A, McEvoy RD, Wheatley JR, O'Donoghue FJ, Rochford PD, Churchward T, Campbell MC, Palme CE, Robinson S, Goding GS, Eckert DJ, Jordan AS, Catcheside PG, Tyler L, Antic NA, Worsnop CJ, Kezirian EJ, Hillman DR. Treating obstructive sleep apnea with hypoglossal nerve stimulation. Sleep. 2011 Nov 1;34(11):1479-86. doi: 10.5665/sleep.1380.
PubMed 22043118
Goding GS Jr, Tesfayesus W, Kezirian EJ. Hypoglossal nerve stimulation and airway changes under fluoroscopy. Otolaryngol Head Neck Surg. 2012 Jun;146(6):1017-22. doi: 10.1177/0194599812436472. Epub 2012 Feb 3.
PubMed 22307575
Schwartz AR, Barnes M, Hillman D, Malhotra A, Kezirian E, Smith PL, Hoegh T, Parrish D, Eastwood PR. Acute upper airway responses to hypoglossal nerve stimulation during sleep in obstructive sleep apnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):420-6. doi: 10.1164/rccm.201109-1614OC. Epub 2011 Dec 1.
PubMed 22135343
Mwenge GB, Dury M, Delguste P, Rodenstein D. Response of automatic continuous positive airway pressure devices in a normal subject. Eur Respir J. 2011 Jun;37(6):1530-3. doi: 10.1183/09031936.00139510. No abstract available.
PubMed 21632834
Oldenburg O, Lamp B, Faber L, Teschler H, Horstkotte D, Topfer V. Sleep-disordered breathing in patients with symptomatic heart failure: a contemporary study of prevalence in and characteristics of 700 patients. Eur J Heart Fail. 2007 Mar;9(3):251-7. doi: 10.1016/j.ejheart.2006.08.003. Epub 2006 Oct 5.
PubMed 17027333
Somers VK, Dyken ME, Clary MP, Abboud FM. Sympathetic neural mechanisms in obstructive sleep apnea. J Clin Invest. 1995 Oct;96(4):1897-904. doi: 10.1172/JCI118235.
PubMed 7560081

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obstructive Sleep Apnea Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Upper AIRway Implanted Nerve STIMulation Therapy: A Breakthrough in Obstructive Sleep Apnea Therapy
ClinicalTrials.gov ID: NCT03844295
Acronym / sponsor ID: AIRSTIM / 38RC18.030
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: stimulation, hypoglossal nerve, Upper-airway
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: University Hospital, GrenobleUniversity, hospital or other
Collaborators: Inspire Medical Systems, Inc.
Study start: 21 Mar 2019 (actual)
Primary completion: 22 Dec 2021 (actual)
Study completion: 10 Oct 2023 (actual)
First posted: 18 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The principal objective of this study is short-term efficacy of a new treatment for OSA on blood pressure variability during sleep.

Detailed description

Obstructive sleep apnea (OSA) syndrome had become over the last decade a serious health concern due to its high prevalence which raise 10% of the general population.

A selection processus will be applied in order to identify the patients that will be good responders to the hypoglossal stimulation.

The main criterion of selection is based on Drug Induced Sleep Endoscopy(DISE) that will be performed by a trained endoscopist dedicated to this study.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: Single blind (participant)
Number of arms: 2
Model description: Monocentric, prospective, controlled, patient single-blind study

Arm	Type	Receives
Activated Inspire® Upper Airway Stimulation System	Experimental	Device: Activated Inspire® Upper Airway Stimulation SystemINSPIRE® device will be active a month
Inactivated Inspire® Upper Airway Stimulation System	Placebo comparator	Device: Inactivated Inspire® Upper Airway Stimulation SystemAfter a period 15 days of "wash-out" the INSPIRE® device will be inactivated for a second period of one month.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patient aged 18 to 80 years old
Patient with moderate to severe OSA based on an established diagnosis of OSA (15≤AHI<65) by polysomnography or respiratory polygraphy not older thant three years.
Patient with moderate to severe OSA naïve of treatment or with difficulty accepting or adhering to CPAP treatment.
Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer to activate the stimulation
Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires

Key exclusion criteria (32 listed)

Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
Have any condition or procedure that has compromised neurological control of the upper airway
Unable to operate the patient programmer
Pregnant or plan to become pregnant, and breastfeeding women
Require magnetic resonance imaging (MRI)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Activated Inspire® Upper Airway Stimulation SystemAt first, INSPIRE® device will be active a month	Device	Activated Inspire® Upper Airway Stimulation System
Inactivated Inspire® Upper Airway Stimulation SystemAfter 15 days "wash-out" INSPIRE® device will be inactivated for a second period of one month.	Device	Inactivated Inspire® Upper Airway Stimulation System

Primary outcome

Short-term efficacy of a new treatment for OSA on systolic blood pressure variability during sleep
Time frame: one month treatment active versus non active treatment
Change in the difference between delta nocturnal systolic blood pressure (difference between maximum and minimal nocturnal systolic blood pressure ; nocturnal period is defined from 10 pm to 7am).

16 secondary outcomes

Short-term efficacy of a new treatment for OSA on mean-24h, daytime and nighttime blood pressure
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on OSA by Epworth sleepiness scale score
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on Apnea-Hypopnea Index measured by polysomnography
Time frame: one month treatment active versus non active treatment
Change in sympatho-vagal balance based on heart rate variability analysis
Time frame: one month treatment active versus non active treatment
Self-reported changes in sleep and quality of life by SF-36 score
Time frame: one month treatment active versus non active treatment
Sleep latency assessed during a Maintenance of Wakefulness Test
Time frame: one month treatment active versus non active treatment
Nocturnal pulse pressure assessed by Continuous Non-invasive Arterial Pressure monitoring
Time frame: one month treatment active versus non active treatment
Short-term efficacy of a new treatment for OSA on diastolic blood pressure variability during sleep
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on OSA by Pichot weakness scale score
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on nocturia
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on morning asthenia
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on morning headache
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on snoring
Time frame: one month treatment active versus non active treatment
Self-reported changes in sleep and quality of life by FOSQ score
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on oxygen desaturation index measured by polysomnography
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on sleep efficacy measured by polysomnography
Time frame: one month treatment active versus non active treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
Background: PubMed 8464434Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
Background: PubMed 11991871Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.
Background: PubMed 17825611Mulgrew AT, Ryan CF, Fleetham JA, Cheema R, Fox N, Koehoorn M, Fitzgerald JM, Marra C, Ayas NT. The impact of obstructive sleep apnea and daytime sleepiness on work limitation. Sleep Med. 2007 Dec;9(1):42-53. doi: 10.1016/j.sleep.2007.01.009. Epub 2007 Sep 6.
Background: PubMed 25142569Lallukka T, Kaikkonen R, Harkanen T, Kronholm E, Partonen T, Rahkonen O, Koskinen S. Sleep and sickness absence: a nationally representative register-based follow-up study. Sleep. 2014 Sep 1;37(9):1413-25. doi: 10.5665/sleep.3986.
Background: PubMed 20525723Tamisier R, Pepin JL, Remy J, Baguet JP, Taylor JA, Weiss JW, Levy P. 14 nights of intermittent hypoxia elevate daytime blood pressure and sympathetic activity in healthy humans. Eur Respir J. 2011 Jan;37(1):119-28. doi: 10.1183/09031936.00204209. Epub 2010 Jun 4.
Background: PubMed 20522795Pepin JL, Tamisier R, Barone-Rochette G, Launois SH, Levy P, Baguet JP. Comparison of continuous positive airway pressure and valsartan in hypertensive patients with sleep apnea. Am J Respir Crit Care Med. 2010 Oct 1;182(7):954-60. doi: 10.1164/rccm.200912-1803OC. Epub 2010 Jun 3.
Background: PubMed 19324954Gagnadoux F, Fleury B, Vielle B, Petelle B, Meslier N, N'Guyen XL, Trzepizur W, Racineux JL. Titrated mandibular advancement versus positive airway pressure for sleep apnoea. Eur Respir J. 2009 Oct;34(4):914-20. doi: 10.1183/09031936.00148208. Epub 2009 Mar 26.
Background: PubMed 24401051Strollo PJ Jr, Soose RJ, Maurer JT, de Vries N, Cornelius J, Froymovich O, Hanson RD, Padhya TA, Steward DL, Gillespie MB, Woodson BT, Van de Heyning PH, Goetting MG, Vanderveken OM, Feldman N, Knaack L, Strohl KP; STAR Trial Group. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014 Jan 9;370(2):139-49. doi: 10.1056/NEJMoa1308659.
Background: PubMed 8880094Mayer P, Pepin JL, Bettega G, Veale D, Ferretti G, Deschaux C, Levy P. Relationship between body mass index, age and upper airway measurements in snorers and sleep apnoea patients. Eur Respir J. 1996 Sep;9(9):1801-9. doi: 10.1183/09031936.96.09091801.
Background: PubMed 22043118Eastwood PR, Barnes M, Walsh JH, Maddison KJ, Hee G, Schwartz AR, Smith PL, Malhotra A, McEvoy RD, Wheatley JR, O'Donoghue FJ, Rochford PD, Churchward T, Campbell MC, Palme CE, Robinson S, Goding GS, Eckert DJ, Jordan AS, Catcheside PG, Tyler L, Antic NA, Worsnop CJ, Kezirian EJ, Hillman DR. Treating obstructive sleep apnea with hypoglossal nerve stimulation. Sleep. 2011 Nov 1;34(11):1479-86. doi: 10.5665/sleep.1380.
Background: PubMed 22307575Goding GS Jr, Tesfayesus W, Kezirian EJ. Hypoglossal nerve stimulation and airway changes under fluoroscopy. Otolaryngol Head Neck Surg. 2012 Jun;146(6):1017-22. doi: 10.1177/0194599812436472. Epub 2012 Feb 3.
Background: PubMed 22135343Schwartz AR, Barnes M, Hillman D, Malhotra A, Kezirian E, Smith PL, Hoegh T, Parrish D, Eastwood PR. Acute upper airway responses to hypoglossal nerve stimulation during sleep in obstructive sleep apnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):420-6. doi: 10.1164/rccm.201109-1614OC. Epub 2011 Dec 1.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Renaud RT TAMISIER, PhD principal investigator

University Hospital, Grenoble

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short-term efficacy of a new treatment for OSA on systolic blood pressure variability during sleep (time frame: one month treatment active versus non active treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03844295, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.