Trial Outcomes & Findings for Lifestyle Modification Program to Treat Obstructive Sleep Apnea Patients (NCT NCT01384760)

NCT ID: NCT01384760

Last Updated: 2015-02-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 185 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2015-02-19

Participant Flow

A total 185 patients were screened and 104 underwent randomization

Participant milestones

Measure	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.	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.
Overall Study STARTED	61	43
Overall Study Randomized	61	43
Overall Study COMPLETED	45	37
Overall Study NOT COMPLETED	16	6

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	0	6
Overall Study Protocol Violation	16	0

Baseline Characteristics

Lifestyle Modification Program to Treat Obstructive Sleep Apnea Patients

Baseline characteristics by cohort

Measure	Lifestyle Modification Program n=61 Participants 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.	Simple Lifestyle Advice n=43 Participants 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.	Total n=104 Participants Total of all reporting groups
Age, Continuous	51.4 years STANDARD_DEVIATION 9.1 • n=5 Participants	52 years STANDARD_DEVIATION 9.3 • n=7 Participants	51.8 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	30 Participants n=7 Participants	78 Participants n=5 Participants
Body mass index (BMI)	30.2 kg/m^2 STANDARD_DEVIATION 3.9 • n=5 Participants	30.5 kg/m^2 STANDARD_DEVIATION 4.2 • n=7 Participants	30.3 kg/m^2 STANDARD_DEVIATION 4.0 • n=5 Participants
Neck circumference (cm)	39.9 cm STANDARD_DEVIATION 3.3 • n=5 Participants	40.3 cm STANDARD_DEVIATION 3.7 • n=7 Participants	40.1 cm STANDARD_DEVIATION 3.5 • n=5 Participants
smoking status never smoke	44 participants n=5 Participants	31 participants n=7 Participants	75 participants n=5 Participants
smoking status quitted smoking	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
smoking status current smoking	11 participants n=5 Participants	6 participants n=7 Participants	17 participants n=5 Participants
AHI - events/hour	43.4 events per hour STANDARD_DEVIATION 20 • n=5 Participants	42.5 events per hour STANDARD_DEVIATION 20 • n=7 Participants	43 events per hour STANDARD_DEVIATION 19.8 • n=5 Participants
minSaO2	69.6 percentage STANDARD_DEVIATION 9.7 • n=5 Participants	65.1 percentage STANDARD_DEVIATION 17.9 • n=7 Participants	67.2 percentage STANDARD_DEVIATION 10.2 • n=5 Participants
Score on Epworth Sleepiness Scale (ESS)	11.4 units on a scale STANDARD_DEVIATION 5.7 • n=5 Participants	10.2 units on a scale STANDARD_DEVIATION 4.7 • n=7 Participants	11.0 units on a scale STANDARD_DEVIATION 5.0 • n=5 Participants

PRIMARY outcome

Timeframe: 1 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.

Outcome measures

Measure	Lifestyle Modification Program n=61 Participants 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.	Simple Lifestyle Advice n=43 Participants 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.
Apnea-hypopnea Index (AHI) at One Year	35.3 events per hour Standard Deviation 21.7	39.6 events per hour Standard Deviation 19.5

SECONDARY outcome

Timeframe: 1 year

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.

Outcome measures

Measure	Lifestyle Modification Program n=61 Participants 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.	Simple Lifestyle Advice n=43 Participants 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.
Epworth Sleepiness Score (ESS)	8.9 units on a scale Standard Deviation 4.8	9.2 units on a scale Standard Deviation 4.9

Adverse Events

Lifestyle Modification Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Simple Lifestyle Advice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Susanna S Ng

ChineseUHK

Phone: (852) 98075787

Email: drsssng123@yahoo.com.hk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place