Obstructive Sleep ApneaQUAVIMAXNCT04618991
Assessment of the Impact on the Quality of Life of Surgically Assisted Maxillary Expansion in Adult Patients Followed for Obstructive Sleep Apnea Syndrome
A study testing Filling the Quebec Sleep Questionnaire in people with Obstructive Sleep Apnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The research aims to assess the impact on quality of life of surgically maxillary expansion in adult patients followed for obstructive sleep apnea syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Filling the Quebec Sleep Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2021to 31 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- With obstructive sleep apnea confirmed by polysomnography
- Surgical indication for surgically maxillary expansion
Who cannot join
- - Patients refusing to participate in the survey having formulated their opposition
- Diabetes,
- Obesity (BMI> 30)
- Failure to provide informed written consent
- Refusal or inability to return to all follow-up visits and sleep studies
- Patient pregnant or planning to become pregnant in the next 12 months or breastfeeding
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- Surgical resection or radiation therapy for cancer or congenital malformations of the larynx, tongue or throat (Note that some previous surgeries, such as uvulopalatopharyngoplasty (UPPP), tonsillectomy or adenoidectomy, to remove obstructions related to obstructive sleep apnea are allowed)
- Obvious obstructions of the fixed upper airways (tumors, polyps or nasal obstruction)
- Patients who have undergone previous surgery on the mandible and / or maxilla, other than dental treatment.
- Patients included in another clinical study (excluding registers).
- Patients taking medicines such as opiates which may affect sleep, alertness or breathing
Trial locations and contacts
1 site in 1 country.
About this study
The research aims to assess the impact on quality of life of surgically maxillary expansion in adult patients followed for obstructive sleep apnea syndrome.
Read the detailed description
This assessment will be done using the following elements:
- The score of the Quebec sleep questionnaire (QSQ), developed in 2004 by Lacasse Y. et al. This questionnaire is specific to sleep apnea and may be self-administered. The main interest of this questionnaire is to measure the change in quality of life over time.
- The Epworth Scale Score, developed in 1991 by Murray W. John. This is a self-administered questionnaire developed to measure daytime sleepiness.
- Gender, age group, BMI
- The radiological assessment
- The results of polysomnography
Patients will be followed for a period of 1 year and one month after surgery. The protocol visits correspond to the rhythm of post-surgery follow-up consultations in current practice.
These patients are followed by Dr. Pételle at Saint-Antoine Hospital. During these visits, they will complete the Quebec sleep questionnaire and the Epworth scale, at baseline, at 3 months and then at 1 year.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Filling the Quebec Sleep Questionnaire
- Keywords
- obstructive sleep apnea, quality of life, surgically assisted rapid maxillary expansion, distraction osteogenesis, palatal expansion technique
- 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.
Filling the Quebec Sleep QuestionnaireOther
Filling the Quebec Sleep Questionnaire (QSQ) by the pre-surgery patient, then at 3 months post surgery and 1 year post surgery.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with SAHOS for whom maxillary transversal surgery | Experimental | Adult patients with SAHOS for whom maxillary transversal surgery is recommended. Receives: Other: Filling the Quebec Sleep Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of the QSQ
Score of the QSQ filled directly by the patient before surgery, compared to that then 3 months after surgery.
Measured: at 3 months
Secondary outcomes (4)
Score of the Quebec Sleep Questionnaire (QSQ)
Score of the QSQ filled directly by the patient before surgery, compared to that then 1 year after surgery.
Measured: at 1 year
Polysomnography
Search for a modification of the polysomnography data before and after surgery
Measured: at 3 months
Epworth scale
Epworth scale score changes before and after surgery
Measured: at 1 year
correlation between the results of the Quebec Sleep Questionnaire (QSQ) score and the anthropometric data
correlation between the results of the QSQ score and the anthropometric data
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start15 Mar 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris Petelle, Study chair, Assistance Publique - Hôpitux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618991
- Sponsor's protocol ID
- APHP201080
- Acronym
- QUAVIMAX
- Status last verified
- Nov 2025
- First submitted
- 15 Oct 2020
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact on the Quality of Life of Surgically Assisted Maxillary Expansion in Adult Patients Followed for Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT04618991
- Acronym / sponsor ID
- QUAVIMAX / APHP201080
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, quality of life, surgically assisted rapid maxillary expansion, distraction osteogenesis, palatal expansion technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 6 Nov 2020 (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 research aims to assess the impact on quality of life of surgically maxillary expansion in adult patients followed for obstructive sleep apnea syndrome.
Detailed description
This assessment will be done using the following elements:
- The score of the Quebec sleep questionnaire (QSQ), developed in 2004 by Lacasse Y. et al. This questionnaire is specific to sleep apnea and may be self-administered. The main interest of this questionnaire is to measure the change in quality of life over time.
- The Epworth Scale Score, developed in 1991 by Murray W. John. This is a self-administered questionnaire developed to measure daytime sleepiness.
- Gender, age group, BMI
- The radiological assessment
- The results of polysomnography
Patients will be followed for a period of 1 year and one month after surgery. The protocol visits correspond to the rhythm of post-surgery follow-up consultations in current practice.
These patients are followed by Dr. Pételle at Saint-Antoine Hospital. During these visits, they will complete the Quebec sleep questionnaire and the Epworth scale, at baseline, at 3 months and then at 1 year.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with SAHOS for whom maxillary transversal surgery | Experimental | Other: Filling the Quebec Sleep QuestionnaireAdult patients with SAHOS for whom maxillary transversal surgery is recommended. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- With obstructive sleep apnea confirmed by polysomnography
- Surgical indication for surgically maxillary expansion
Key exclusion criteria (11 listed)
- - Patients refusing to participate in the survey having formulated their opposition
- Diabetes,
- Obesity (BMI> 30)
- Failure to provide informed written consent
- Refusal or inability to return to all follow-up visits and sleep studies
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 |
|---|---|---|
| Filling the Quebec Sleep QuestionnaireFilling the Quebec Sleep Questionnaire (QSQ) by the pre-surgery patient, then at 3 months post surgery and 1 year post surgery. | Other | Adult patients with SAHOS for whom maxillary transversal surgery |
Primary outcome
Score of the QSQ
Time frame: at 3 months
Score of the QSQ filled directly by the patient before surgery, compared to that then 3 months after surgery.
4 secondary outcomes
Score of the Quebec Sleep Questionnaire (QSQ)
Time frame: at 1 year
Polysomnography
Time frame: at 3 months
Epworth scale
Time frame: at 1 year
correlation between the results of the Quebec Sleep Questionnaire (QSQ) score and the anthropometric data
Time frame: at 1 year
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 20 Nov 2025.
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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.
Boris Petelle study chair
Assistance Publique - Hôpitux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filling the Quebec Sleep Questionnaire in people with Obstructive Sleep Apnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 11 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 20 Nov 2025. 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. 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?
Score of the QSQ (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2025.