Combination Therapy Associating CPAP and Mandibular Advancement Device in OSA

NCT04021810 | Terminated

• 1 other identifier: 38RC17.350
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of this study is to evaluate the efficacy of a combination of Continuous Positive Airway Pressure (CPAP) and a Mandibular Advancement Device (MAD) on nocturnal Blood Pressure control in hypertensive patients in obstructive sleep apnea low CPAP compliers (less than 4 hours per night). Hypertensive patients demonstrating low CPAP adherence will be selected during a screening visit; they will be then randomized to one of the three following arms: Education to CPAP ("CPAP only"), Treatment by a MAD ("MAD only") or a combination of both CPAP and MAD ("CPAP+MAD"). Mean systolic, diastolic, diurnal and nocturnal blood pressure will be assessed during 24-h Ambulatory Blood Pressure monitoring, before and after a 3-month treatment intervention. Biological laboratory parameters, patients reported outcomes (daytime sleepiness and Quality of Life), will also be evaluated before and after 3 months of treatment.

Conditions

Obstructive Sleep Apnea Syndrome; Hypertension

Keywords

Sleep Apnea; CPAP; Mandibular Advancement Device; Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Nightime Mean Blood Pressure

  Difference in nighttime Mean Blood Pressure before and after treatment, measured by ambulatory blood pressure

  3 months

Secondary Outcomes (13)

• Other 24h ambulatory blood pressure measurements

  3 months

• Blood Pressure Variability

  3 months

• Percent Dippers/dipping phenotypes

  3 months

• 3-days home Blood Pressure measurements (systolic, diastolic)

  3 months

• Epworth Score

  3 months

Study Arms (3)

CPAP only

ACTIVE COMPARATOR

Obstructive sleep apnea patients with CPAP treatment only

Device: Continuous Positive Airway Pressure (CPAP) and patient education

Mandibular Advancement Device only

ACTIVE COMPARATOR

Obstructive sleep apnea patients with Mandibular Advancement Device only

Device: Mandibular Advancement Device

CPAP + Mandibular Advancement Device

EXPERIMENTAL

Obstructive sleep apnea patients with combined CPAP and Mandibular Advancement Device

Device: Continuous Positive Airway Pressure (CPAP) and patient education; Device: Mandibular Advancement Device

Interventions

Continuous Positive Airway Pressure (CPAP) and patient education DEVICE

Mask connected to a pump (CPAP machine) that forces air into the nasal passages at pressures high enough to overcome obstructions in the airways. Plus patient education.

CPAP + Mandibular Advancement Device; CPAP only

Mandibular Advancement Device DEVICE

Adjustable oral prosthesis which retains the lower mandible in an anterior position, thus limiting sleep apneas

CPAP + Mandibular Advancement Device; Mandibular Advancement Device only

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Arterial Hypertension (Clinical Blood Pressure \> 140/90 mmHg or patient under medication with nocturnal hypertension seen in the Ambulatory Blood Pressure Measurement)
• Severe obstructive sleep apnea syndrome, treated by CPAP for more than 6 months and less than 5 years, with a compliance \<4h/night
• No contraindication to a treatment by Mandibular Advancement Device
• Ability to understand study procedures and signed informed consent
• Covered by French social security system or equivalent

You may not qualify if:

• Central Obstructive Apnea (\>20% Central Apneas/Hypopneas)
• Pregnant or breastfeeding womens
• Prisoners or persons who require protection by the law
• Contraindication to a mandibular advancement device (oral-dental pathology, pathology of the temporo-mandibular articulation, poor periodontal status)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• ONIRIS: collaborator

Study Sites (4)

Nouvelle Clinique Bel Air

Bordeaux, 33073, France

Location

University Hospital Grenoble

Grenoble, 38000, France

Location

University Hospital Montpellier

Montpellier, France

Location

Cabinet Médical

Perpignan, 66000, France

Location

Related Publications (11)

• 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.

  PMID: 8464434 RESULT

• Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.

  PMID: 15781100 RESULT

• Kendzerska T, Gershon AS, Hawker G, Leung RS, Tomlinson G. Obstructive sleep apnea and risk of cardiovascular events and all-cause mortality: a decade-long historical cohort study. PLoS Med. 2014 Feb 4;11(2):e1001599. doi: 10.1371/journal.pmed.1001599. eCollection 2014 Feb.

  PMID: 24503600 RESULT

• Bailly S, Destors M, Grillet Y, Richard P, Stach B, Vivodtzev I, Timsit JF, Levy P, Tamisier R, Pepin JL; scientific council and investigators of the French national sleep apnea registry (OSFP). Obstructive Sleep Apnea: A Cluster Analysis at Time of Diagnosis. PLoS One. 2016 Jun 17;11(6):e0157318. doi: 10.1371/journal.pone.0157318. eCollection 2016.

  PMID: 27314230 RESULT

• Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15.

  PMID: 27188535 RESULT

• Bratton DJ, Gaisl T, Schlatzer C, Kohler M. Comparison of the effects of continuous positive airway pressure and mandibular advancement devices on sleepiness in patients with obstructive sleep apnoea: a network meta-analysis. Lancet Respir Med. 2015 Nov;3(11):869-78. doi: 10.1016/S2213-2600(15)00416-6. Epub 2015 Oct 20.

  PMID: 26497082 RESULT

• Pepin JL, Tamisier R, Baguet JP, Lepaulle B, Arbib F, Arnol N, Timsit JF, Levy P. Fixed-pressure CPAP versus auto-adjusting CPAP: comparison of efficacy on blood pressure in obstructive sleep apnoea, a randomised clinical trial. Thorax. 2016 Aug;71(8):726-33. doi: 10.1136/thoraxjnl-2015-207700. Epub 2016 Apr 18.

  PMID: 27091542 RESULT

• 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.

  PMID: 20522795 RESULT

• Malhotra A, Orr JE, Owens RL. On the cutting edge of obstructive sleep apnoea: where next? Lancet Respir Med. 2015 May;3(5):397-403. doi: 10.1016/S2213-2600(15)00051-X. Epub 2015 Apr 14.

  PMID: 25887980 RESULT

• Bratton DJ, Gaisl T, Wons AM, Kohler M. CPAP vs Mandibular Advancement Devices and Blood Pressure in Patients With Obstructive Sleep Apnea: A Systematic Review and Meta-analysis. JAMA. 2015 Dec 1;314(21):2280-93. doi: 10.1001/jama.2015.16303.

  PMID: 26624827 RESULT

• Mokhlesi B, Hagen EW, Finn LA, Hla KM, Carter JR, Peppard PE. Obstructive sleep apnoea during REM sleep and incident non-dipping of nocturnal blood pressure: a longitudinal analysis of the Wisconsin Sleep Cohort. Thorax. 2015 Nov;70(11):1062-9. doi: 10.1136/thoraxjnl-2015-207231. Epub 2015 Aug 25.

  PMID: 26307037 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypertension; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure; Occlusal Splints

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Jean-Louis Pépin, Pr, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: July 16, 2019
• Study Start: November 18, 2019
• Primary Completion: March 3, 2020
• Study Completion: May 18, 2021
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)