the primary objective of this study is to investigate whether a structured program including exercise training and dietary advice is feasible in mild OSAS patients in a primary care setting.
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility assessed by patient compliance to the treatment: number of patients
dropping out of the program; percentage training sessions attended by each
patient; usage of the pedometer; amount of times patient fills in the diary.
Secondary outcome
Fat-free mass, weight, subjective daytime sleepiness, health related quality of
life, the influence of excessive sleep on physical-, mental- and social
functioning in daily life, symptoms of current depression and anxiety,
activities of daily living, compliance with treatment, intima-media thickness
(IMT) of the carotid arteries, Advanced Glycation Endproducts (AGEs).
Background summary
Obstructive sleep apnea-hypopnea syndrome (OSAS) is a common sleep-related
breathing disorder characterized by repetitive upper airway collapse during
sleep, disruptive snoring and excessive daytime sleepiness. Many OSAS patients
are characterized by obesity. As obesity is probably the most important risk
factor for OSAS and the number of people with obesity is increasing, the
prevalence as well as the incidence of OSAS will probably increase even
further. Specific lifestyle patterns often play a predominant role in
developing obesity and helping obese OSAS patients in changing their lifestyle
patterns is probably of great importance. Recently an evidence based guideline
on diagnostics and treatment of OSAS in adults was presented. This guideline
recommends that in all OSAS patients conservative measures (i.e. weight
reduction, avoidance of stimulants in the evening, avoidance of sedative
medication and alteration of sleeping position) should be considered first.
Conservative measures may be effective in mild OSAS. However, studies that
investigated the effectiveness of the conservative measures were of evidence
level 3. Therefore, within the mild spectrum of OSAS further research is needed
to investigate the effects of conservative measures on OSAS symptoms. This
pilot study will increase our knowledge in the specific area of lifestyle
intervention and will provide information on the feasibility of the study.
Study objective
the primary objective of this study is to investigate whether a structured
program including exercise training and dietary advice is feasible in mild OSAS
patients in a primary care setting.
Study design
the protocol concerns a longitudinal study without a control group.
Intervention
patients with mild OSAS will receive a structered program, consisting of
exercise training and dietary advice for 24 weeks, with follow-up measurements
after 12 and 24 weeks.
Study burden and risks
on three moments (baseline, 12 weeks, 24 weeks) fat-free mass will be assessed,
cardiovascular risk will be assessed, 4 questionnaires have to be filled in,
and a walking test has to be performed. After 12 and 24 weeks the number of
apneas and/or hypopneas will be assessed during ambulant polysomnography.
Benefits of the treatments could be a reduction of the number of apneas and/or
hypopneas per hour, reduction of subjective daytime sleepiness, improvement in
quality of life, and on the long term reduction in cardiovascular risk.
Postbus 30001
9700 RB Groningen
Nederland
Postbus 30001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
1. Individuals who have been subjected to polysomnography and are diagnosed as having mild (5<=AHI<15) OSAS
2. Aged > 20 years
3. Body mass index (BMI) > 25
Exclusion criteria
1. Patients with previous treatment for OSAS (continuous positive airway pressure (CPAP), oral-appliance therapy, uvulopalatopharyngoplasty (UPPP))
2. Morphologic abnormalities of the upper airway (e.g., a compromised nasal passage, enlarged tonsils or adenoids, or upper airway soft-tissue or craniofacial abnormality)
3. Endocrine dysfunction (hypothyroidism, acromegaly, or pituitary adenoma)
4. Reported or documented severe cardiac- or pulmonary co-morbidity (daytime respiratory insufficiency, severe chronic obstructive pulmonary disease (COPD), heart failure, coronary disease, or severe cardiac arrhythmias)
5. Psychiatric disorders (e.g., depression or schizophrenia)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27839.042.09 |