None listed
Conditions
Brief summary
The primary purpose of the study is to ascertain if delivering higher levels of humidity to patients undergoing CPAP treatment for Obstructive Sleep Apnea will result in greater comfort; better sleep quality and increased compliance with treatment. Our hypothesis is that supports this theory. There are two STUDY ARMS: CPAP + (conventional heated humidification) CPAP + (optimal level of humidity) STAGE 1: Participants will be randomised to 2 nights of full sleep study. (one night on each of the study arms) Outcome measures: Sleep quality (measured once after each nightime study) STAGE 2: After completion of stage 1 of the study particpants will be re-randomised to one of the two study arrms for three weeks at home on this arm. After completion of this 3 weeks particpants will be swapped to the alternate arm. Outcome measures: Compliance (recorded at the end of each 3-week arm) Subjective symptom score; relating to comfort (recorded at the end of each 3-week arm)
Interventions
STUDY ARMS:
CPAP + (optimal level of humidity)
STAGE 1:
Participants will be randomised to 2 nights of full sleep study. (one night on each of the study arms)
Outcome measures:
Sleep quality (measured once after each nightime study)
STAGE 2:
After completion of stage 1 of the study particpants will be re-randomised to one of the two study arrms for three weeks at home on this arm. After completion of this 3 weeks particpants will be swapped to the alternate arm.
Outcome measures:
STUDY ARMS: CPAP + (optimal level of humidity) STAGE 1: Participants will be randomised to 2 nights of full sleep study. (one night on each of the study arms) Outcome measures: Sleep quality (measured once after each nightime study) STAGE 2: After completion of stage 1 of the study particpants will be re-randomised to one of the two study arrms for three weeks at home on this arm. After completion of this 3 weeks particpants will be swapped to the alternate arm. Outcome measures: Compliance (recorded at the end of each 3-week arm) Subjective symptom score; relating to comfort (recorded at the end of each 3-week arm)
Sponsors
self funded by hospital -Klinik Ambrock, Klinik fur Pneumologie, Universitat Witten-Herdecke, Hagen.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Newly diagnosed obstructive sleep apnea > 10 AHI.
Exclusion criteria
Therapy intolerance determined in the PSG-CPAP titration studyVentilatory insufficiencyMalignant herat rythmn Pregnancy.
Outcome results
None listed