AzTrials
AzTrials

Obstructive Sleep ApneaNCT06538701

Effect of ALA on Retrolingual Collapse in Patients With Multilevel Obstructive OSA

A study testing Anterolateral advancement pharyngoplasty in people with Obstructive Sleep Apnea, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

To determine the effect of Anterolateral advancement pharyngoplasty on retrolingual collapse in patients with multilevel OSA, and thus if multistage surgery is required. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
Anterolateral advancement pharyngoplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
No sites listed yet
Study dates
1 Oct 2024to 1 Oct 2026
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age: ≥ 18 and ≤ 60 years.
  • Sex: both genders.
  • BMI: less than 32 kg/m2
  • Patients with moderate (AHI = 15-30) and severe OSA (AHI > 30) according to the clinical guidelines given by the American Academy of Sleep Medicine
  • Friedman tongue position III or IV.
  • Documented failure/refusal of attempts of conservative treatment measures (not limited to continuous positive airway pressure).
  • The presence of type II obstruction (oropharynx and hypopharynx).
  • Class I occlusion.

Who cannot join

  • Age: < 18 or > 60 years old.
  • BMI: >32 kg/m2
  • Failure to attend postoperative follow-up polysomnography within 12 months of surgery.
  • Previous surgery to the base of the tongue or other surgical treatment of OSA.
  • Chronic pulmonary disease, or other previous oropharyngeal/laryngeal surgery.
  • Class II occlusion with receding mandible.
  • Huge lymphoid tissue of the tongue and/or lingual tonsil.
  • Symptom not suggestive of OSA and presence of central sleep apnea.

Trial locations and contacts

No sites are listed yet.

Ahmed AA Mostafa, Ass lecturer contact

01060451679 ext. +2

dr.ahmed.ayman94@aun.edu.eg

About this study

Official title: Effect of Anterolateral Advancement Pharyngoplasty on Retrolingual Collapse in Patients With Multilevel Obstructive Sleep Apnea

To determine the effect of Anterolateral advancement pharyngoplasty on retrolingual collapse in patients with multilevel OSA, and thus if multistage surgery is required.

Read the detailed description

Obstructive sleep apnea (OSA) is a condition characterized by repeated episodes of partial or complete airway obstruction during sleep. It is a common health problem affecting a large proportion of the population even among different ethnic groups. At ≥5 events/h apnea-hypopnea index (AHI), the general population prevalence ranged from 9 % to 38 % and was higher in men. The problem increases with advancing age and, in some elderly groups, was as high as 90 % in men and 78 % in women. The prevalence among the adult population ranged from 6 % to 17 % at ≥15 events/h AHI, being as high as 49 % within the advanced ages. The etiology of OSA is multifactorial, consisting of a complex interplay between anatomic, neuromuscular factors and an underlying genetic predisposition toward the disease. Many risk factors have been identified to increase the susceptibility to the disease, including obesity, male sex, ethnicity, and craniofacial structure. The body response to obstructed breathing leads to brain arousal, sympathetic activation, and oxygen desaturation in the blood. This leads to sleep fragmentation, excessive daytime sleepiness and impaired productivity and quality of life (QOL). Obstructive sleep apnea (OSA) has a drastic effect on increasing morbidity and mortality which has been linked to cardiovascular (resistant hypertension, acute myocardial infarction, atrial fibrillation and ventricular tachycardia) and cerebrovascular diseases (stroke, epilepsy and Alzheimer's). Furthermore, OSA has been associated with higher rates of unintentional injury, including motor vehicle collisions and work-related injuries, which add to the public health burden. A polysomnogram (PSG) is an integral component of many sleep evaluations. Attended (Type I) PSGs are the gold standard for diagnosing sleep-related breathing disorders (SRBD), including OSA. The study consists of a simultaneous recording of several physiologic parameters during sleep and wakefulness, including the electroencephalogram (EEG) to identify wake versus sleep and its stages. The main metric for diagnosing OSA in PSG is AHI. According to AHI, the American Academy of Sleep Medicine (AASM) classify the severity of OSA into: Mild with AHI of 5 to <15, moderate with AHI of 15 to 30 and severe with AHI of >30. There are several diagnostic tools which can be useful for the OSA patients' clinical examination, but awake fiberoptic nasopharyngeal endoscopy represents the first level diagnostic technique performed in such patients. The drug-induced sleep endoscopy (DISE) has been introduced to overcome the limits of the awake nasopharyngeal endoscopy. Imaging techniques for diagnosis of OSA include: cephalometric study, fluoroscopy, acoustic reflection, computerized tomography (CT), and magnetic resonance imaging (MRI). Continuous positive airway pressure (CPAP) is the first line treatment option for moderate to severe cases of OSA. CPAP is a highly efficacious therapy for OSA however, poor adherence to therapy can limit the effectiveness of treatment. In OSA patients, obstruction may occur at oropharynx type I, oropharynx and hypopharynx type II, or hypopharynx type III. Most patients have type II obstruction involving both the soft palate and the tongue base. The surgical treatment of OSA patients aimed at widening the diameter of the upper airways by means of resection, advancement and/or suspension, or volumetric reduction of their anatomical structures. Surgical efficacy is linked to the successful identification of the location of the obstruction and its successful correction without causing significant iatrogenic damage, especially if the patient's OSA is not particularly severe. Surgical success is classically defined as a 50% or greater reduction in AHI to less than 20 events per hour. The importance of the lateral pharyngeal wall (LPW) in the pathogenesis of OSA has been demonstrated in a series of articles. In patients with OSA, the LPW is thicker and more collapsible than that of normal subjects when pressured by the airflow. Through progressive increase of positive pressure in a normal subject, enlargement of airway lumen appears mainly in its lateral dimensions, with reduction of thickness of the LPW and with minimal changes in soft palate and tongue. Except when controlling for body mass index (BMI) and neck circumference, LPW narrowing appears to be the sole independent oropharyngeal finding that carries a risk factor for male OSA patients. Uvulopalatopharyngoplasty (UPPP) was first described by akamatsu in 1964, then Fujita introduced it in the USA in 1981. Due to its low success rate and considerable associated complications, the role of this procedure has been questioned, and in the last 2 decades, many modifications of UPPP have been recommended. The recent evolution regarding the techniques of pharyngoplasty has focused on the concept of obtaining expansion and stabilization of the pharyngeal airspace through the treatment of LPW collapse rather than through ablation of redundant pharyngeal soft tissue space. Newer techniques include Lateral pharyngoplasty , Z-palatoplasty, Expansion sphincter pharyngoplasty (ESP) , Relocation pharyngoplasty , Barbed reposition pharyngoplasty (BRP) and, in 2016, Amara et al. described Anterolateral advancement pharyngoplasty (ALA) with no tissue resection nor muscle cutting at all, except for tonsillectomy if not performed before. There are many surgical techniques for retrolingual collapse, they include genioglossus advancement and its different modifications till the more recent one modified genioglossus advancement , radiofrequency tongue base reduction (RFTBR), Tongue base suspension technique and its modifications. Because the airway is a unified system, and the most common cause of retrolingual collapse is glossoptosis caused by negative pressure exerted on the tongue base as a result of palatal and LPW obstruction, relieving obstruction at the palate and LPW will improve obstruction at the tongue base level, eliminating the need for multistage surgery.

Being tested
Anterolateral advancement pharyngoplasty
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.

  • Anterolateral advancement pharyngoplastyProcedure or surgery

    Starting with bilateral tonsillectomy, The palatopharyngeal muscle (PPM) raised and advanced to be fixed to the pterygomandibular raphe, The posterior part of the PPM, together with its attached mucosa, was then advanced superolaterally behind the palatoglossus muscle to be hooked up to the levator veli palatini muscle

Study groups in NCT06538701
Study groupRoleWhat they receive
Anterolateral advancement pharyngoplastyExperimentalStarting with bilateral tonsillectomy, The palatopharyngeal muscle (PPM) raised and advanced to be fixed to the pterygomandibular raphe, The posterior part of the PPM, together with its attached mucosa, was then advanced superolaterally behind the palatoglossus muscle to be hooked up to the levator veli palatini muscle
Receives: Procedure: Anterolateral advancement pharyngoplasty

What is being measured

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

  1. determine the changes in apnea-hypopnea index (AHI) in multilevel OSA patients with Anterolateral advancement pharyngoplasty

    we assess pre- and post-operative polysomnogram to detect if there is changes in AHI (per hour of sleep)

    Measured: Baseline

  2. determine the changes in diameter of retrolingual airway in multilevel OSA patients with Anterolateral advancement pharyngoplasty .

    we assess pre- and post-operative cephalometry to detect if there is changes in diameter of retrolingual airway (in mm).

    Measured: Baseline

Timeline

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

  1. First posted6 Aug 2024
  2. Study start1 Oct 2024 (estimated)
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06538701
Sponsor's protocol ID
ALA in OSA patients
Status last verified
Jul 2024
First submitted
23 Jul 2024
Last updated
6 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cahali MB. Lateral pharyngoplasty: a new treatment for obstructive sleep apnea hypopnea syndrome. Laryngoscope. 2003 Nov;113(11):1961-8. doi: 10.1097/00005537-200311000-00020.

    PubMed 14603056
  • DeRowe A, Gunther E, Fibbi A, Lehtimaki K, Vahatalo K, Maurer J, Ophir D. Tongue-base suspension with a soft tissue-to-bone anchor for obstructive sleep apnea: preliminary clinical results of a new minimally invasive technique. Otolaryngol Head Neck Surg. 2000 Jan;122(1):100-3. doi: 10.1016/S0194-5998(00)70152-5.

    PubMed 10629491
  • Dicus Brookes CC, Boyd SB. Controversies in Obstructive Sleep Apnea Surgery. Sleep Med Clin. 2018 Dec;13(4):559-569. doi: 10.1016/j.jsmc.2018.07.005.

    PubMed 30396449
  • Li HY, Lee LA. Relocation pharyngoplasty for obstructive sleep apnea. Laryngoscope. 2009 Dec;119(12):2472-7. doi: 10.1002/lary.20634.

    PubMed 19688851
  • Powell NB, Riley RW, Guilleminault C. Radiofrequency tongue base reduction in sleep-disordered breathing: A pilot study. Otolaryngol Head Neck Surg. 1999 May;120(5):656-64. doi: 10.1053/hn.1999.v120.a96956.

    PubMed 10229589
  • Riley R, Guilleminault C, Powell N, Derman S. Mandibular osteotomy and hyoid bone advancement for obstructive sleep apnea: a case report. Sleep. 1984;7(1):79-82. doi: 10.1093/sleep/7.1.79.

    PubMed 6718928
  • Vicini C, De Vito A, Benazzo M, Frassineti S, Campanini A, Frasconi P, Mira E. The nose oropharynx hypopharynx and larynx (NOHL) classification: a new system of diagnostic standardized examination for OSAHS patients. Eur Arch Otorhinolaryngol. 2012 Apr;269(4):1297-300. doi: 10.1007/s00405-012-1965-z. Epub 2012 Feb 19.

    PubMed 22350494

Questions about this trial

What is this clinical trial studying?

A study testing Anterolateral advancement pharyngoplasty in people with Obstructive Sleep Apnea, run by Assiut University.

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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Ahmed AA Mostafa, Ass lecturer (01060451679 ext. +2, dr.ahmed.ayman94@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

determine the changes in apnea-hypopnea index (AHI) in multilevel OSA patients with Anterolateral advancement pharyngoplasty (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT06538701, which also lists 7 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 6 Aug 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in