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Lifestyle Modification Program to Treat Obstructive Sleep Apnea Patients

A Randomized Controlled Study to Examine the Effect of Lifestyle Modification Program in Obstructive Sleep Apnea Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01384760
Acronym
OSA
Enrollment
185
Registered
2011-06-29
Start date
2011-01-31
Completion date
2014-03-31
Last updated
2015-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Brief summary

Obstructive sleep apnea syndrome (OSAS) is a common form of sleep-disordered breathing (SDB) characterized by repetitive episodes of cessation of breathing during sleep due to upper airway collapse. It causes sleep fragmentation, disabling daytime sleepiness, impaired cognitive function and poor quality of life. In addition, OSAS is associated with non-fatal and fatal cardiovascular consequences including sudden death, in addition to an increased risk of road traffic accidents. Continuous positive airway pressure (CPAP) is considered as the first-line treatment for OSA. Oral appliance has been shown to reduce the severity of sleep disordered breathing and leads to symptomatic improvement especially in mild to moderate OSA. The compliance with CPAP is low particularly in mild or moderate OSA patients and it is not a curative treatment of OSA. It has to be used in every night on a regular basis. Weight reduction has always been advocated in patients with OSA who are overweight and may lead to improvement in the severity of OSA. The existing studies about weight loss are limited by small sample size, short duration (\<6 months), focus on very low calorie diet program or surgically induced weight loss program only. However, none of them have applied lifestyle modification program (LMP) which emphasizes on long term lifestyle and behavior change. Therefore, the investigators plan to conduct a randomized controlled trial among Chinese OSA patients by comparing the efficacy of LMP against usual clinical lifestyle advice alone on the improvement of OSA symptoms.

Detailed description

Obstructive sleep apnea syndrome (OSAS) is a common form of sleep-disordered breathing (SDB) characterized by repetitive episodes of cessation of breathing during sleep due to upper airway collapse. It causes sleep fragmentation, disabling daytime sleepiness, impaired cognitive function and poor quality of life. In addition, OSAS is associated with non-fatal and fatal cardiovascular consequences including sudden death, in addition to an increased risk of road traffic accidents. OSAS is equally common among the middle-aged male Caucasian and Hong Kong (HK) Chinese populations with prevalence rates of at least 4%. The prevalence and severity of OSAS tend to increase through adult life, peaking in the late fifties to mid sixties, after which it fails to increase or decrease. Another group of investigators reported high prevalence rates of SDB in a group aged 65-95 years of 70% for men and 56% for women, at least double those reported for middle-aged cohorts. Risk factors for OSA include obesity, increasing age, being male, abnormal craniofacial morphology, nasal obstruction, genetic factors. OSA is associated with several cardiovascular consequences and social consequences e.g. motor vehicle accidents, impaired cognitive performance, depression. Various epidemiologic studies have shown an association between OSA and hypertension. In cross-sectional study, OSA was associated with increased prevalence of self-reported heart failure and stroke. OSA has been shown to be independently associated with coronary artery disease after adjustment for traditionally considered risk factors. Continuous positive airway pressure (CPAP) is considered as the first-line treatment for OSA. Oral appliance has been shown to reduce the severity of sleep disordered breathing and leads to symptomatic improvement especially in mild to moderate OSA. The compliance with CPAP is low particularly in mild or moderate OSA patients and it is not a curative treatment of OSA. It has to be used in every night on a regular basis. Weight reduction has always been advocated in patients with OSA who are overweight and may lead to improvement in the severity of OSA. A population-based longitudinal study showed that a 10% weight loss predicted a 26% decrease in apnoea-hypopnoea index (AHI), a count of the number of upper airway obstructions per hour of sleep. The existing studies about weight loss are limited by small sample size, short duration (\<6 months), focus on very low calorie diet program or surgically induced weight loss program only. However, none of them have applied lifestyle modification program (LMP) which emphasizes on long term lifestyle and behavior change. Therefore, the investigators plan to conduct a randomized controlled trial among Chinese OSA patients by comparing the efficacy of LMP against usual clinical lifestyle advice alone on the improvement of OSA symptoms. Aim of the study: The investigators aim to test the hypothesis that LMP is superior to lifestyle advice alone in the management of Chinese patients with OSA. The primary outcome measure is the change of AHI. The secondary outcome measures are changes in quality of life, symptoms related to OSA, glucose, and insulin metabolism parameters. Hypothesis: The investigators hypothesize that more OSA patients in a low glycemic index dietary intervention program than patients receiving simple lifestyle advice alone will have reduction in AHI.

Interventions

BEHAVIORALLifestyle modification

During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.

Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Age 30 to 80 years * AHI ≥ 5/hour * Body mass index (BMI) greater than or equal to 25 * Written informed consent obtained

Exclusion criteria

* Presence of sleepiness which may constitute risk to self or others * Chronic kidney, thyroid, or liver disease * Coexistence of sleep disorders other than OSA * History of previous surgery to upper airway (except those for nasal problems) * Previous surgical or current medical treatment for OSA Pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Apnea-hypopnea Index (AHI) at One Year1 yearAHI is a count of the number of upper airway obstruction per hour of sleep. The index will be derived from the overnight home sleep study.

Secondary

MeasureTime frameDescription
Epworth Sleepiness Score (ESS)1 yearThe Epworth Sleepiness Scale (ESS) is a questionnaire for assessing daytime sleepiness. It was first described in 1991 as a simple, self-administered questionnaire. The questionnaire is based on eight common situations in life. Subjects are asked to rate on a scale of 0-3 about how likely they would fall asleep or doze off in these circumstances. This gives a total score of 0 to 24 in each subject.The total score ranges from 0 to 24, with higher scores indicating higher sleepiness.

Countries

China

Participant flow

Recruitment details

A total 185 patients were screened and 104 underwent randomization

Participants by arm

ArmCount
Lifestyle Modification Program
Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
61
Simple Lifestyle Advice
Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
43
Total104

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up06
Overall StudyProtocol Violation160

Baseline characteristics

CharacteristicLifestyle Modification ProgramSimple Lifestyle AdviceTotal
Age, Continuous51.4 years
STANDARD_DEVIATION 9.1
52 years
STANDARD_DEVIATION 9.3
51.8 years
STANDARD_DEVIATION 7.8
AHI - events/hour43.4 events per hour
STANDARD_DEVIATION 20
42.5 events per hour
STANDARD_DEVIATION 20
43 events per hour
STANDARD_DEVIATION 19.8
Body mass index (BMI)30.2 kg/m^2
STANDARD_DEVIATION 3.9
30.5 kg/m^2
STANDARD_DEVIATION 4.2
30.3 kg/m^2
STANDARD_DEVIATION 4
minSaO269.6 percentage
STANDARD_DEVIATION 9.7
65.1 percentage
STANDARD_DEVIATION 17.9
67.2 percentage
STANDARD_DEVIATION 10.2
Neck circumference (cm)39.9 cm
STANDARD_DEVIATION 3.3
40.3 cm
STANDARD_DEVIATION 3.7
40.1 cm
STANDARD_DEVIATION 3.5
Score on Epworth Sleepiness Scale (ESS)11.4 units on a scale
STANDARD_DEVIATION 5.7
10.2 units on a scale
STANDARD_DEVIATION 4.7
11.0 units on a scale
STANDARD_DEVIATION 5
Sex: Female, Male
Female
13 Participants13 Participants26 Participants
Sex: Female, Male
Male
48 Participants30 Participants78 Participants
smoking status
current smoking
11 participants6 participants17 participants
smoking status
never smoke
44 participants31 participants75 participants
smoking status
quitted smoking
6 participants6 participants12 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 450 / 43
serious
Total, serious adverse events
0 / 450 / 43

Outcome results

Primary

Apnea-hypopnea Index (AHI) at One Year

AHI is a count of the number of upper airway obstruction per hour of sleep. The index will be derived from the overnight home sleep study.

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Lifestyle Modification ProgramApnea-hypopnea Index (AHI) at One Year35.3 events per hourStandard Deviation 21.7
Simple Lifestyle AdviceApnea-hypopnea Index (AHI) at One Year39.6 events per hourStandard Deviation 19.5
Secondary

Epworth Sleepiness Score (ESS)

The Epworth Sleepiness Scale (ESS) is a questionnaire for assessing daytime sleepiness. It was first described in 1991 as a simple, self-administered questionnaire. The questionnaire is based on eight common situations in life. Subjects are asked to rate on a scale of 0-3 about how likely they would fall asleep or doze off in these circumstances. This gives a total score of 0 to 24 in each subject.The total score ranges from 0 to 24, with higher scores indicating higher sleepiness.

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Lifestyle Modification ProgramEpworth Sleepiness Score (ESS)8.9 units on a scaleStandard Deviation 4.8
Simple Lifestyle AdviceEpworth Sleepiness Score (ESS)9.2 units on a scaleStandard Deviation 4.9

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026