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

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 - AFOHER

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56434

Enrollment

186

Registered

2023-11-27

Start date

2024-05-02

Completion date

Unknown

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obstructive sleepapnea OSA

Interventions

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 postmenopausa

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: women, AHI >=5, age between18-71, demonstrable daytime sleepiness (ESS >=10 or by anamnesis) and/or other OSA-related complaints such as insomnia, difficulty in day time functioning, mood swings, fatigue and CPAP as treatment

Exclusion criteria

Exclusion criteria: Unable to understand what the questionnaires contain and/or not willing to cooperate. Younger than 18 and older than 70 years

Design outcomes

Primary

Measure	Time frame
Sleep related impairment Do women with OSA treated with Autoset For Her have a better improvement in sleep-related impairment compaired to Autoset standard ( measured by - Quality of life (PROMIS® 1.3Global02) which content next subjects: - - Social functioning (Promis® 2.0, ability to participate in social roles and activities short form 4A) - - Physical functioning (PROMIS® 2.0 physical functioning short form 8b) - - Anxiety (PROMIS®, Anxiety short form 4a) - - Depression (PROMIS® 1.0 Depression short form 4A) - - Fatigue (PROMIS® 1.0 fatigue short form 4A) - - Pain (PROMIS® 1.0 Numerical Assessment Score Pain Intensity - - Problems with Sleep Disorders (PROMIS®, 1.0 )	—

Measure

Time frame

Sleep related impairment Do women with OSA treated with Autoset For Her have a better improvement in sleep-related impairment compaired to Autoset standard ( measured by - Quality of life (PROMIS® 1.3Global02) which content next subjects: - - Social functioning (Promis® 2.0, ability to participate in social roles and activities short form 4A) - - Physical functioning (PROMIS® 2.0 physical functioning short form 8b) - - Anxiety (PROMIS®, Anxiety short form 4a) - - Depression (PROMIS® 1.0 Depression short form 4A) - - Fatigue (PROMIS® 1.0 fatigue short form 4A) - - Pain (PROMIS® 1.0 Numerical Assessment Score Pain Intensity - - Problems with Sleep Disorders (PROMIS®, 1.0 )

—

Secondary

Measure	Time frame
- The difference in adherence/duration of use of CPAP therapy after 10 weeks for the total group with distinction between Autoset FH and standard Autoset - Comfort by Visual Analog Scale (VAS) - Reason for stopping CPAP for the entire group and distinction between pre- and postmenopausal women • CPAP infidelity; Despite maximum guidance, CPAP is not applied by the patient or for insufficient time. • CPAP intolerance; CPAP is not well tolerated based on side effects and/or psychological aversion. • CPAP effectiveness failure; CPAP has insufficient physiological effect: the AHI is not sufficiently lowered. • failure of CPAP symptoms; CPAP has sufficient physiological effect, but insufficient symptomatic effect. (OSA Adult Guideline, NVALT 2018) -. - The difference in CPAP pressure between Autoset FH and Autoset standard after 10 weeks (95% pressure) - ESS (Questionnaire ESS) (Appendix)	—

Measure

Time frame

- The difference in adherence/duration of use of CPAP therapy after 10 weeks for the total group with distinction between Autoset FH and standard Autoset - Comfort by Visual Analog Scale (VAS) - Reason for stopping CPAP for the entire group and distinction between pre- and postmenopausal women • CPAP infidelity; Despite maximum guidance, CPAP is not applied by the patient or for insufficient time. • CPAP intolerance; CPAP is not well tolerated based on side effects and/or psychological aversion. • CPAP effectiveness failure; CPAP has insufficient physiological effect: the AHI is not sufficiently lowered. • failure of CPAP symptoms; CPAP has sufficient physiological effect, but insufficient symptomatic effect. (OSA Adult Guideline, NVALT 2018) -. - The difference in CPAP pressure between Autoset FH and Autoset standard after 10 weeks (95% pressure) - ESS (Questionnaire *ESS*) (Appendix)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)