Influence of Craniofacial Restriction on Rebound of Obstructive Sleep Apnea Following Weight Gain

NCT03051815 | Completed

• 1 other identifier: OSA-MMV/Ng/2016
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Apart from obesity, craniofacial factors are well recognized in the pathogenesis of obstructive sleep apnea (OSA) and are likely to play an important role in influencing the response to weight loss. The prevalence of OSA syndrome is as common among the middle-aged Hong Kong Chinese populations as the Caucasians, despite our Chinese patients having much lower body mass index (BMI). From previous work on ethnic comparison, for the same degree of OSA severity, Caucasians were more overweight, whereas Chinese exhibited more craniofacial bony restriction. Cephalometric measurements based on lateral radiograph of the upper airway have shown that a shorter distance between maxillary projection from the cranial base, a smaller posterior airway space, less mandibular protrusion, a narrower space between the hard palate and cranial base, and a more caudally placed hyoid bone predispose to a higher apnea-hypopnea index (AHI). A recent study shown that a shorter mandibular length as measured by lateral cephalometry was associated with a greater fall in AHI after weight loss. Another study using craniofacial computed tomography (CT) scans to evaluate the maxillomandibular bony volume found that craniofacial restriction influenced the relationship between weight loss and OSA improvement. Collectively, these studies suggest that the effect on AHI with weight loss is likely to be more pronounced in those with a smaller craniofacial skeleton. However, the effect of the craniofacial restriction on the degree of rebound in OSA following weight gain after the weight loss intervention is unknown. The study aims to investigate the change in weight and OSA severity following cessation of a lifestyle modification program (LMP) and examine the relationship between craniofacial restriction and the degree of OSA reoccurrence.

Conditions

Observation

Keywords

obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• Change in apnea-hypopnea index (AHI)

  7 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects are participants in a previously described dietician-based weight loss study in obese Chinese with obstructive sleep apnea (OSA) in which 61 subjects underwent a 12-month weight loss program consisting of dietician consultation with caloric reduction of 10% to 20% in daily energy intake from the patient's usual diet and then the goal was adjusted subsequently based on changes in body weight with target BMI toward 23 kg/m2 om the uear pf 2010-2013. Specific study entry criteria included an age range between 30 and 80 years, body mass index (BMI) \>25 kg/m2, and moderate to severe OSA (apnea-hypopnea index (AHI) \>15/hr) before the weight loss program performed in the year of 2010-2013. All subjects from the intervention group will be invited to participate.

You may qualify if:

• Subjects are participants in a previously described dietician-based weight loss study in obese Chinese with obstructive sleep apnea (OSA). Specific study entry criteria included an age range between 30 and 80 years, body mass index (BMI) \>25 kg/m2, and moderate to severe OSA (apnea-hypopnea index (AHI) \>15 events/hour) before the weight loss program performed in the year of 2010-2013.

You may not qualify if:

• Subjects refused to participate the trial or unable to consent.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Susanna So-Shan Ng, MBChB

  Hospital Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Assistant Professor

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 14, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 4, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)