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Effect of Weight Loss and CPAP on OSA and Metabolic Profile Stratified by Craniofacial Phenotype

11 febbraio 2021 aggiornato da: Susanna SS Ng, Chinese University of Hong Kong

Obstructive sleep apnea (OSA) is a common form of sleep-disordered breathing (SDB). Weight reduction has always been advocated in patients with OSA who are overweight and may lead to improvement in the severity of OSA. Previous study reported a randomized controlled trial of dietician-led lifestyle modification program (LMP) in 104 patients and found that LMP group had significantly more weight loss and reduced OSA severity, and the response was sustained after 8 months.

This study is aimed to compare the effect of weight loss or CPAP alone on subclinical inflammation, insulin resistance and blood pressure in patients with obesity and moderate-to-severe obstructive sleep apnea, stratified according to the degree of craniofacial restriction.

The study plans to recruit consecutive patients who have been referred to the Respiratory Clinic at the Prince of Wales Hospital with clinical suspicion of sleep-disordered breathing with specific study entry criteria including an age of 18 or more, body mass index (BMI) >25 kg/m2, and moderate to severe OSA diagnosed by home sleep study. Patients having conditions that will affect the serum level of hsCRP will be excluded.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Obstructive sleep apnea (OSA) is a common form of sleep-disordered breathing (SDB). It causes sleep fragmentation, disabling daytime sleepiness, impaired cognitive function, poor quality of life and cardiovascular diseases. Weight reduction has always been advocated in patients with OSA who are overweight and may lead to improvement in the severity of OSA. Previous study reported a randomized controlled trial of dietician-led lifestyle modification program (LMP) in 104 patients and found that LMP group had significantly more weight loss and reduced OSA severity, and the response was sustained after 8 months. However, a wide variety of response to the therapy was observed with 21.3% of patients with severe disease that converted to mild to moderate and only 6.6% of those with severe disease who became mild in severity. Apart from obesity, craniofacial factors are well recognized in the pathogenesis of OSA and are likely to play an important role in influencing the response to weight loss. For the same degree of OSA severity, Caucasians were more overweight whereas Chinese exhibited more craniofacial bony restriction. Recent studies showed that a smaller craniofacial skeleton is associated with better response from weight loss program in terms of OSA improvement. With vast majority of studies investigating the cardiometabolic changes after CPAP or weight loss on patients with OSA, evaluation based on craniofacial restriction, the key factor in the pathogenesis, is lacking.

This study aimed to compare the effect of weight loss or CPAP alone on subclinical inflammation, insulin resistance and blood pressure in patients with obesity and moderate-to-severe obstructive sleep apnea, stratified according to the degree of craniofacial restriction.

The study plans to recruit consecutive patients who have been referred to the Respiratory Clinic at the Prince of Wales Hospital with clinical suspicion of sleep-disordered breathing with specific study entry criteria including an age of 18 or more, body mass index (BMI) >25 kg/m2, and moderate to severe OSA diagnosed by home sleep study. Patients having conditions that will affect the serum level of hsCRP will be excluded.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

194

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Hong Kong
      • Hong Kong, Hong Kong
        • Chinese University of Hong

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patients diagnosed with moderate or severe obstructive sleep apnea ( apnea hypopnea index (AHI) ≥ 15); body mass index ≥25 kg/m2; age 18-70 years.

Exclusion Criteria:

  • Predominant central sleep apnea; conditions that will affect the level of hsCRP; unstable cardiovascular disease (e.g. recent unstable angina, myocardial infarction, stroke or transient ischemic attack within the previous 6 months or severe left ventricular failure; neuromuscular disease affecting or potentially affecting respiratory muscles; moderate to severe respiratory disease (i.e. breathlessness affecting activities of daily living) or documented hypoxemia or awake SaO2 <92%); psychiatric disease that limits the ability to give informed consent or complete the study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Lifestyle modification program group
Patients with apnea-hypopnea index (AHI) ≥ 15/hr on home sleep study will participate in a dietitian-led lifestyle modification program (LMP) for 6 months. Patients will attend dietary consultation weekly in the first 4 months, and then monthly in the following two months.
Comportamentale: Lifestyle modification
A caloric reduction of 10-20% in daily energy intake from the patient's usual diet (i.e. a deficit ≥ 200 calories per day) will be set as the general initial goal, which will be adjusted subsequently based on changes in body weight with target body mass index (BMI) towards 23 kg/m2.
Altro: CPAP group
Patients randomized into the continuous positive airway pressure (CPAP) group in each arm will be interviewed by the physician on duty and invited to start autoCPAP treatment for 6 months. They will be offered a CPAP education package. Patients will then commence autoCPAP treatment for 6 months at home.
Dispositivo: Continuous positive airway pressure (CPAP)
Patients randomized into the continuous positive airway pressure (CPAP) group in each arm will be interviewed by the physician on duty and invited to start autoCPAP treatment for 6 months. They will be offered a CPAP education package. Patients will then commence autoCPAP treatment for 6 months at home.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
changes in hsCRP
Lasso di tempo: 6 months
6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
change in Epworth Sleepiness Scale (ESS)
Lasso di tempo: 6 months
6 months
Change of insulin sensitivity by Matsuda index
Lasso di tempo: 6 months
6 months
Change of facial measurements on photography
Lasso di tempo: 6 months

Frontal and profile digital photographs of the head and neck are obtained with a standardized setup. A digital camera is mounted on a tripod at a distance of 160 cm from the subject alignment plane.

Subjects are photographed standing upright while assuming the natural head position. Standardized methods are used to align subjects for the photographs. For the frontal photograph, the subject's facial landmark nasion is aligned along the subject alignment plane while ensuring both ears are seen equally from the front. For the profile photograph, the subject is instructed to turn 90 degrees to the left after the frontal photograph was taken.

The subject's mid-sagittal plane is aligned to the subject alignment plane. Using image analysis software (Image J v1.36, NIH, Bethesda, MD), the photographs are examined for landmark digitization.
6 months
Change of anatomic measurements of upper airway on computed tomography imaging
Lasso di tempo: 6 months
All subjects will perform a three-dimensional (3D) computed tomography (CT) scans of the head/neck region to evaluate the size of the maxillomandibular volume (MMV) based on the mandibular cephalometric landmarks (left and right condylion, left and right gonion, and menton). All measurements will be made by a single assessor and the analysis will be performed blind to knowledge of AHI data.
6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chinese University of Hong Kong

Investigatori

  • Investigatore principale: Susanna SS Ng, MBChB, Chinese University of Hong Kong
  • Investigatore principale: Susanna Ng, MBChB, Chinese University of Hong Kong

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 settembre 2017

Completamento primario (Effettivo)

31 agosto 2020

Completamento dello studio (Effettivo)

31 agosto 2020

Date di iscrizione allo studio

Primo inviato

14 settembre 2017

Primo inviato che soddisfa i criteri di controllo qualità

15 settembre 2017

Primo Inserito (Effettivo)

19 settembre 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 febbraio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 febbraio 2021

Ultimo verificato

1 febbraio 2021

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • OSA-Craniofacial study

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

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