The primary objective is to evaluate the percentage of the study population who have OSAS before and after treatment and the severity of it. A second objective is to correlate the prevalence of OSAS with different tumour sites and stages, as well as…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of OSAS in 3 populations with Head and neck cancer
Secondary outcome
Influence of treatment on the OSAS
Background summary
Titel: *Prospective cohort study on the prevalence of obstructive sleep apnea
in patients with head and neck cancer treated with either radiotherapy,
chemoradiation or surgery*
Obstructive sleep apnea syndrome (OSAS) is the most common sleep disorder and
increasingly recognised as a major health problem. The prevalence of OSAS in
the middle aged population is 2% of women and 4% of men (1). In the Netherlands
40,000 men and 20,000 women suffer from OSAS (2).
OSAS is defined by the American Academy of Sleep Medicine Task Force (1999) as
more than five obstructive apneas or hypopneas per hour of sleep and excessive
daytime sleepiness, not explained by other factors, or two or more of the
following symptoms: gasp for breath during sleep, repeated nocturnal awakening,
non recuperative sleep, diurnal fatigue and altered concentration (3). The
severity of OSAS is expressed in the apnea hypopnea index (AHI). An AHI of 5-15
is mild OSAS, an AHI of 15-30 is moderate and AHI >30 is severe OSAS, as
assessed by polysomnography (4).
Unfortunately approximately 80% of OSAS patients remain undiagnosed and
patients with atypical symptoms may go unrecognized (5,6). Awareness of the
risk factors for the development of OSAS makes it possible to determine which
patients should be screened for this condition.
OSAS is being treated because of its complaints, but also since it is becoming
increasingly clear that OSAS is associated with considerable comorbidity,
including hypertension and increased risk for other cardiovascular diseases.
Identification and treatment of OSAS may be an important factor in improving
quality of life (7).
A growing body of literature is suggesting that there is a link between head
and neck cancer treated with radiation therapy or surgery and the development
of OSAS (6 - 18).
Study objective
The primary objective is to evaluate the percentage of the study population who
have OSAS before and after treatment and the severity of it. A second objective
is to correlate the prevalence of OSAS with different tumour sites and stages,
as well as different treatments and to study the correlation between the
different variables with OSAS.
Study design
prospective cohort study
Study burden and risks
Patients have to fill in a questionnaire and have to have 2 sleep registrations
in the Lucas-Andreas Hospital.
No risks involved.
The possible benefit is that they are timely diagnosed with OSAS and can be
treated.
Plesmanlaan 121
1066 CX
NL
Plesmanlaan 121
1066 CX
NL
Listed location countries
Age
Inclusion criteria
T2-4 laryngeal carcinoma, treated with radiotherapy
T3-4 oral and oropharyngeal carcinoma treated with a commandoprocedure (with/without postoperative (chemo)radiation.)
T2-4 oro- or hypopharyngeal cancer treated with chemoradiation
Exclusion criteria
Age older than 18 or younger than 80
Stridor and need for tracheostomy before/during treatment
Inability to undergo polysomnography
Inability to complete questionnaires
Other conditions deemed by the Principle Investigator that make the subject ineligible for protocol procedures
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 | NL28916.031.09 |