Research with human participants

Overview of medical research in the Netherlands

Prevalence of Obstructive Sleep Apnea (OSA) after treatment for advance stage head and neck cancer

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Last updated:

1. To evaluate the prevalence of obstructive sleep apnea (OSA) in patients after treatment for advanced stage head and neck cancer2. To identify subgroups with higher risk of OSA within this cohort (e.g. tumor site and treatment type)3. To evaluate…

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Upper respiratory tract disorders (excl infections)
Study type
Observational non invasive

ID

NL-OMON48756

Source

ToetsingOnline

Brief title

Prevalence of sleepapnea after treatment for head and neck cancer

Condition

  • Upper respiratory tract disorders (excl infections)

Synonym

obstructive sleep apnea, sleep apnea

Research involving

Human

Sponsors and support

Primary sponsor :
Antoni van Leeuwenhoek Ziekenhuis
Source(s) of monetary or material Support :
Ministerie van OC&W,Vivisol

Intervention

Keyword :
Head and neck cancer, Obstructive Sleep Apnea, Prevalence

Outcome measures

Primary outcome

Prevalence of obstructive sleep apnea

Secondary outcome

Subgroups with a higher risk on obstructive sleep apnea and the difference in

quality of life between patients with and without obstructive sleep apnea

Background summary

Obstructive Sleep Apnea (OSA) has proven to be associated with significant
morbidity and mortality. Since OSA seems to have a negative impact on quality
of life, the recognition and treatment of OSA in head and neck cancer survivors
may contribute to an improvement of their quality of life. However, accurate
numbers on the extent of the problem among head and neck cancer patients and
results on high risk subgroups lack.

Study objective

1. To evaluate the prevalence of obstructive sleep apnea (OSA) in patients
after treatment for advanced stage head and neck cancer
2. To identify subgroups with higher risk of OSA within this cohort (e.g. tumor
site and treatment type)
3. To evaluate the effect of OSA on quality of life of patients of this cohort
4. To evaluate the effect of treatment of OSA on quality of life of patients of
this cohort

Study design

Prospective cross-sectional study

Study burden and risks

Not applicable

Public
Antoni van Leeuwenhoek Ziekenhuis

Plesmanlaan 121
Amsterdam 1066 CX
NL
Scientific
Antoni van Leeuwenhoek Ziekenhuis

Plesmanlaan 121
Amsterdam 1066 CX
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

More than one year after treatment for T3-4 oral cavity, oropharynx, hypopharynx or larynx cancer.

Exclusion criteria

Not applicable

Design

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Other

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
196
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC NedMec
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC NedMec
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC NedMec

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 NL63971.031.17