Autoset S11 For Her versus Autoset S11 standard in women with symptomatic OSA; Do women with OSA treated with Autoset For Her have a better improvement in sleep-related impairment compaired to Autoset standard . A randomized clinical Trial of an Intervention

Nevertheless, little research has been done to date on the effect of CPAP on
the reduction of complaints such as mood swings, insomnia and daytime
functioning in women with symptomatic OSA.
In addition, it is not known whether less women stop using the Autoset For Her
compared to the standard AutoseIn recent years. More attention has been paid in
the media and among doctors to the fact that men and women show differences.
The number of women with OSA is increasing, which means that more knowledge and
insight is needed to provide women with better tailored treatment.

We use the autoset S11, which has both the standard and the For Her (FH)
algorithm


In 2021 visited 1800 patients the outpatient clinic of the Center for Sleep
Medicine Amphia, with the diagnosis of sleep apnea. There were 1150 men and
650 women. We see an increase in the number of women who report complaints that
may be consistent with sleep apnea.

Until now, little research has been done into the effect on symptoms and
compliance of Continuous Positive Airway Pressure (CPAP) in women with
obstructive sleep apnea (OSA). Many studies of symptomatic OSA have been
conducted in a predominantly male population.

Resmed has developed a CPAP algorithm specifically for premenopausal women with
sleep apnea; Autoset For Her (FH) (S10-FH/ S11 FH = both devices have the same
algorithm) (from now on it will be referred as S11), the algorithm of this CPAP
device also responds to flow limitations and not only to the hypopneas and
apneas. Flow limitations are more likely to give rise to arousals in
premenopausal women. This means that S11 FH rises with pressure earlier than
the standard S11, which should ensure that women sleep better and wake up less
quickly, although they have less complaints. A 2015 study shows that for women
the algorithm works just as well on a decrease in AHI as standard CPAP [28].


In addition, it is not known whether women experience more comfort from the
device and fewer women stop using the Autoset For Her compared to the standard
Autoset. In recent years, more attention has been paid in the media and among
physicians to the fact that men and women show differences. The number of women
with OSA is increasing, which means that more knowledge and insight is needed
to provide women with better tailored treatment.
We are also curious whether this algorithm also has a positive effect on the
postmenopausal group.
We use the Autoset S11, which has both the standard and the For Her algorithm.

The objective of this study is to find out whether women with OSA treated with
Autoset For Her experience a greater improvement in sleep-related problems
compared to the Autoset standard.

We also want to investigate whether the pressure is higher with the S11 FH
compared to the S11, the comfort of both devices, effect in complaints, which
group has more dropouts (with reason) and what the operating time is for both
devices.

RCT Autoset FH versus Autoset

Protocol

1. Inclusion criteria: women, AHI >=5, 18-71 yrs, daytime sleepiness (ESS >= 10
or by history) and/or other OSA-related complaints such as insomnia, daytime
functioning difficulties, mood swings, fatigue , CPAP as a treatment
Exclusion criteria: unwilling to cooperate, unable to understand what the
questionnaires contain

2. Informed consent
Provide patient information letter,
After consent: sign informed consent with OSAS nurse

3. Randomization via Castor

4. Baseline characteristics:
Age, AHI, premenopausal/postmenopausal, BMI, neck circumference, race,
premenopausal/postmenopausal, ODI (oxigen desaturation index), ESS (Epworth
sleepiness scale)

5. Complete questionnaires (PROMIS) before starting CPAP via Castor

6. Call after 2/3 days by the OSAS nurse; first questions are answered and
questions are asked about the first nights with CPAP

7. Appointment OSAS nurse after 3 weeks for reading and discussion about use,
problems and opportunity to ask questions. CPAP reading last week = T1

8. Complete questionnaires (PROMIS) 1 day before the appointment with the
practitioner via Castor

9. Appointment with therapist and OSAS nurse after 10 (+/- 1 week) weeks:
evaluation of therapy, fill in adherence (T2;2 weeks before and 95% pressure),
read AHI and possibly the reason for failure, comfortscore APAP
End study

group 1: S11 FH
group 2: S11

randomised startification
per arm 8 blocks: 8 x 10 participants
1 block of 10 is divided into postmenopausal / premenopausal, with 6
participants in the postmenopausal arm; with an additional distribution of 3 x
S11 FH and 3 x S11 standard
4 participants in the premenopausal arm, with an additional distribution of 2 x
S11 FH and 2 x S11 standard

Load: extra 2 times 10 minutes for completing the questionnaires
Risks: none, equipment has been extensively tested.

The study by Cross et al. (2006) shows that a titration with PSG in the clinic
or a titration at home with CPAP shows an equally good score and pressure
setting. We choose to hospitalize patients at home until an adequate pressure
is found
.
The said questionnaires and software of the readout program have a predictive
validity, it can be said with some certainty that the patients have an
improvement on the outcome measures